Monday, May 18, 2026

Genentech to Present New Data at ASCO 2026, Reinforcing Giredestrant's Potential to Transform the Treatment Paradigm in Early Breast Cancer

• New giredestrant data from the lidERA study on its potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages 
• Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease
• Overall, nine approved and investigational medicines, including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules, with ASCO data targeting urgent needs in breast, blood, lung and other cancers

South San Francisco, CA -- May 18, 2026 --

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), will present new data from nine approved and investigational medicines across more than 15 indications at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 29 to June 2 in Chicago. 

 

"Genentech’s ASCO data reflect our commitment to addressing those cancers that impose the highest burden on patients and society," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "In particular, our ASCO data highlight significant advances in breast cancer, including the latest results for giredestrant and our evolving approach to HER2-positive metastatic disease." 

 

Redefining the standard of care in breast cancer
 Genentech's ASCO 2026 focus is on giredestrant, an investigational, oral, selective estrogen receptor degrader (SERD) being studied in early and advanced estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. 

 This subtype accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early stage. Data from three Phase III trials demonstrate giredestrant's potential as a future standard of care endocrine therapy across multiple disease stages:

• lidERA Breast Cancer: Building on the transformational results shared in December 2025, which demonstrated a 30% reduction in the risk of invasive disease recurrence or death, new data will indicate whether the efficacy and safety of giredestrant remain consistent across pre- and post-menopausal patients with early breast cancer. The lidERA data have been submitted to the U.S. Food and Drug Administration (FDA).
• persevERA Breast Cancer: Primary results investigating giredestrant in combination with palbociclib as a first-line therapy in locally advanced or metastatic cancer will be presented. These data will provide context following the announcement that while the study did not meet its primary endpoint, the giredestrant combination showed a numerical improvement in this distinct patient population, suggesting that giredestrant is active in the first-line setting.
• evERA Breast Cancer: New post-progression treatment analyses will be shared exploring the sustained clinical benefit for people treated with giredestrant plus everolimus in the post-cyclin-dependent kinase 4/6 inhibitor setting. The U.S. FDA recently accepted the New Drug Application for giredestrant based on the positive evERA data.

Our ASCO data also highlight progress in HER2-positive breast cancer, an area Genentech has led for over 30 years:

• RG6596/ZN-A-1041 in HER2-positive breast cancer: Preliminary results from a Phase Ic expansion trial will provide early information on the safety and efficacy of ZN-A-1041, a highly blood-brain barrier-permeable, HER2-selective tyrosine kinase inhibitor, in combination with other HER2-targeted therapies, for patients with pre-treated HER2-positive metastatic breast cancer. Designed for enhanced brain penetration, ZN-A-1041 may improve the ability to prevent and treat brain metastases, a major challenge in metastatic breast cancers.

Advancing precision medicine and novel combinations  
 Genentech is also presenting data from its diverse pipeline targeting specific genetic drivers and difficult-to-treat cancers, including:

• Divarasib in non-small cell lung cancer (NSCLC): Genentech will present results from the Krascendo 170 Phase Ib/II study evaluating the next-generation oral KRAS G12C inhibitor divarasib combined with pembrolizumab in treatment-naive patients with KRAS G12C+ advanced NSCLC. These data informed the Phase III Krascendo 2 study, which investigates this combination as a first-line therapy regardless of PD-L1 status. Divarasib is currently being evaluated in three pivotal Phase III studies as a monotherapy or in chemotherapy-free combinations.
• Lunsumio^® (mosunetuzumab) plus Polivy^® (polatuzumab vedotin) in diffuse large B-cell lymphoma (DLBCL): Genentech will present updated data from the Phase III SUNMO trial to further establish the efficacy and safety of Lunsumio plus Polivy compared to chemotherapy (R-GemOx) particularly in second-line patients with relapsed/refractory DLBCL who are not eligible for transplant. This first combination of a bispecific antibody and antibody-drug conjugate could potentially provide patients who often face poor prognoses and significant treatment burdens with an effective, fixed-duration, chemotherapy-free regimen.

 

Overview of key presentations featuring Genentech medicines and molecules:

Medicine or molecule	Abstract title	Abstract number/ presentation details
Breast cancer
Giredestrant	Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the Phase III persevERA Breast Cancer (BC) trial	#LBA1006 oral    Breast Cancer — Metastatic   Tuesday June 2, 2026 11:45 - 11:57 AM CDT
Giredestrant	Efficacy and safety of giredestrant (GIRE) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the Phase III lidERA BC clinical trial: Results by menopausal status	#502 oral   Breast Cancer —Local/Regional/Adjuvant   Saturday May 30, 2026 1:39 - 1:51 PM CDT
Giredestrant	Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A Phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i)	#1016 rapid oral     Breast Cancer — Metastatic   Sunday May 31, 2026  12:00 - 12:06 PM CDT
RG6596/ ZN-A-1041	Safety and efficacy of ZN-A-1041, a highly blood–brain barrier (BBB)-permeable HER2 tyrosine kinase inhibitor (TKI), + trastuzumab deruxtecan (T-DXd) or pertuzumab-trastuzumab (PH) in HER2-positive metastatic breast cancer (HER2+ mBC): Phase Ic expansion results from the ZN-A-1041-101-US trial	#1055 poster   Breast Cancer — Metastatic   Monday June 1, 2026 1:30 - 4:30 PM CDT
Itovebi® (inavolisib)	Outcomes by lobular (lob) histology status at initial diagnosis in patients (pts) in the INAVO120 Phase III trial with PIK3CA-mutated (mut), hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC) treated with inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV)	#1079 poster   Breast Cancer — Metastatic   Monday June 1, 2026 1:30 - 4:30 PM CDT
Kadcyla® (trastuzumab emtansine)	Adjuvant antibody–drug conjugate (ADC) eligibility and corresponding prognosis in HER2+ early breast cancer (eBC): A US-based real-world comparison of KATHERINE and DESTINY-Breast05 populations	#535 poster   Breast Cancer —Local/Regional/Adjuvant   Monday June 1, 2026 1:30 - 4:30 PM CDT
Blood cancer
Lunsumio® (mosunetuzumab) and Polivy® (polatuzumab vedotin)	Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the Phase III SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups	#7007 oral   Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia   Saturday May 30, 2026  5:12 - 5:24 PM CDT
Columvi® (glofitamab)	Fixed-duration glofitamab monotherapy in relapsed/refractory (R/R) mantle cell lymphoma (MCL) with/without prior Bruton's tyrosine kinase inhibitor (BTKi) exposure: updated data after a 3.5-year follow-up	#7006 oral   Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia   Saturday May 30, 2026  5:00 - 5:12 PM CDT
Polivy	Outcomes by LymphoMAP archetypes in untreated diffuse large B-cell lymphoma from the POLARIX trial	#7017 rapid oral   Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia   Friday May 29, 2026 2:12 - 2:18 PM CDT
Columvi, Lunsumio and Polivy	Multivariable analyses (MVAs) of overall survival (OS) in the Phase III SUNMO, STARGLO and POLARGO trials in relapsed/refractory large B-cell lymphoma (LBCL)	#7093 poster   Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia   Monday June 1, 2026  9:00 - 12:00 PM CDT
Lung cancer
Divarasib	First-line (1L) divarasib plus pembrolizumab (pembro) in advanced or metastatic KRAS G12C+ non-small cell lung cancer (NSCLC): results from the Krascendo-170 study	#8510 clinical science symposium    Lung Cancer — Non-Small Cell Metastatic   Saturday May 30, 2026  8:36 - 8:48 AM CDT
Tecentriq® (atezolizumab)	Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the Phase III IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) maintenance treatment (Tx) in extensive-stage small-cell lung cancer (ES-SCLC)	#8014 rapid oral   Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers   Sunday May 31, 2026 5:12 - 5:18 PM CDT
Tecentriq	IMforte: Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of first-line maintenance (1Lm) treatment (Tx) with lurbinectedin (lurbi) + atezolizumab (atezo) vs atezo in extensive-stage small cell lung cancer (ES-SCLC)	#8086 poster     Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers   Sunday May 31,  2026 9:00 - 12:00 PM CDT
Gastrointestinal cancer
Tecentriq	IMbrave251: Final analysis of atezolizumab (atezo) plus lenvatinib (lenva) or sorafenib (sora) vs lenva or sora alone in locally advanced or metastatic hepatocellular carcinoma (LA/mHCC) previously treated with atezo and bevacizumab (bev)	#4002 oral   Gastrointestinal Cancer —Gastroesophageal, Pancreatic, and Hepatobiliary   Monday June 1, 2026 10:09 - 10:21 AM CDT
Tecentriq	Health-related quality of life (HRQOL) in the Phase III trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502, ATOMIC)*	#3626 poster   Gastrointestinal Cancer —Colorectal and Anal   Saturday May 30,  2026 9:00 - 12:00 PM CDT
Bladder cancer
Tecentriq	Patient-reported outcomes from IMvigor011: A Phase III study of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC)	#4627 poster   Genitourinary Cancer — Kidney and Bladder   Sunday May 31, 2026 9:00 - 12:00 PM CDT

*Study led by the Alliance for Clinical Trials in Oncology and supported by Genentech

[1] Lunsumio and Lunsumio VELO U.S. Indication

Lunsumio (mosunetuzumab-axgb) or Lunsumio VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

 

It is not known if Lunsumio or Lunsumio VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

 

Important Safety Information

What is the most important information I should know about Lunsumio or Lunsumio VELO?

Lunsumio or Lunsumio VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio or Lunsumio VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including: 

• fever of 100.4°F (38°C) or higher
• chills
• low blood pressure
• fast or irregular heartbeat
• tiredness or weakness
• difficulty breathing
• headache
• confusion
• feeling anxious
• dizziness or light-headedness
• nausea
• vomiting 

Due to the risk of CRS, you will receive Lunsumio or Lunsumio VELO on a “step-up dosing schedule.”

• The step-up dosing schedule is when you receive smaller “step-up” doses before receiving higher doses of Lunsumio or Lunsumio VELO during your first cycle of treatment
• If your dose of Lunsumio or Lunsumio VELO is delayed for any reason, you may need to repeat the “step-up dosing schedule”
• You may receive medicines to help reduce your risk of CRS before your dose

Your healthcare provider will check you for CRS during treatment with Lunsumio or Lunsumio VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio or Lunsumio VELO, if you have severe side effects.

What are the possible side effects of Lunsumio or Lunsumio VELO?

Lunsumio or Lunsumio VELO can cause serious side effects, including:

• Neurologic problems. Lunsumio or Lunsumio VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio or Lunsumio VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio or Lunsumio VELO, including:
• headache
• numbness and tingling of the arms, legs, hands, or feet
• dizziness
• confusion and disorientation
• difficulty paying attention or understanding things
• forgetting things or forgetting who or where you are
• trouble speaking, reading or writing
• sleepiness or trouble sleeping
• tremors
• loss of consciousness
• seizures
• muscle problems or muscle weakness
• loss of balance or trouble walking
• tiredness 
• Serious infections. Lunsumio or Lunsumio VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio or Lunsumio VELO, including:
• fever of 100.4°F (38°C) or higher
• cough
• chest pain
• tiredness
• shortness of breath
• painful rash
• sore throat
• pain during urination
• feeling weak or generally unwell
• Hemophagocytic lymphohistiocytosis (HLH). Lunsumio or Lunsumio VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with Lunsumio or Lunsumio VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
• fever
• enlarged spleen
• easy bruising
• low blood cell counts
• liver problems 
• Low blood cell counts. Low blood cell counts are common during treatment with Lunsumio or Lunsumio VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio or Lunsumio VELO. Lunsumio or Lunsumio VELO can cause the following low blood cell counts:
• low white blood cell counts (lymphopenia [for Lunsumio VELO only] and neutropenia). Low white blood cells can increase your risk for infection
• low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
• low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
• Growth in your tumor or worsening of tumor-related problems (tumor flare). Lunsumio or Lunsumio VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio or Lunsumio VELO:
• chest pain
• cough
• trouble breathing
• tender or swollen lymph nodes
• pain or swelling at the site of the tumor 

Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio or Lunsumio VELO if you develop severe side effects.

The most common side effects of Lunsumio include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of Lunsumio VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels.

 

The most common severe abnormal blood test results with Lunsumio VELO include: decreased white blood cell counts and increased uric acid levels.

 

Before receiving Lunsumio or Lunsumio VELO, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had an infusion reaction after receiving Lunsumio
• have an infection or have had an infection in the past which lasted a long time or keeps coming back
• have or have had Epstein-Barr Virus
• are pregnant or plan to become pregnant. Lunsumio or Lunsumio VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio or Lunsumio VELO

Females who are able to become pregnant:

• your healthcare provider should do a pregnancy test before you start treatment with Lunsumio or Lunsumio VELO
• use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio or Lunsumio VELO
• are breastfeeding or plan to breastfeed. It is not known if Lunsumio or Lunsumio VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio or Lunsumio VELO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

What should I avoid while receiving Lunsumio or Lunsumio VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of Lunsumio or Lunsumio VELO. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio or Lunsumio VELO.

 

You may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Genentech at (888) 835-2555.

 

Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide and Lunsumio VELO full Prescribing Information and Medication Guide and on https://www.Lunsumio.com.

 

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).

 

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

 

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

• Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
• Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
• Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
• Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections 
• Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
• Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
• Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

 

Side effects seen most often

The most common side effects during treatment were

• Nerve problems in arms and legs
• Nausea
• Tiredness or lack of energy
• Diarrhea
• Constipation
• Hair loss
• Redness and sores of the lining of the mouth, lips, throat, and digestive tract

 

Polivy may lower your red or white blood cell counts and increase uric acid levels.

 

Polivy may not be for everyone. Talk to your doctor if you are

• Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
• Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
• Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose

 

These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment. 

 

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

 

Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information.

 

What is Itovebi? 

Itovebi^® (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

 

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

 

It is not known if Itovebi is safe and effective in children.

 

Important Safety Information  

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

• High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
• difficulty breathing
• nausea and vomiting (lasting more than 2 hours)
• stomach pain
• excessive thirst
• dry mouth
• more frequent urination than usual or a higher amount of urine than normal
• blurred vision
• unusually increased appetite
• weight loss
• fruity-smelling breath
• flushed face and dry skin
• feeling unusually sleepy or tired
• confusion
• Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
• pain
• redness
• swelling
• ulcers
• Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea

 

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

 

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

• decreased white blood cell counts, red blood cell counts, and platelet counts
• decreased blood levels of calcium, potassium, sodium, and magnesium
• increased creatinine blood levels
• tiredness
• increased blood levels of the liver enzyme alanine transaminase (ALT)
• nausea
• rash
• loss of appetite
• COVID-19 infection
• headache

 

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

 

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683.

 

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of diabetes or high blood sugar
• have kidney problems
• are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.

           Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
• You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.

          Males with female partners who are able to become pregnant:

• You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
• are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit https://www.itovebi.com.

 

Kadcyla U.S. Indication Statement

Kadcyla is approved as an adjuvant (after surgery) treatment for HER2-positive early breast cancer when the patient has taken neoadjuvant (before surgery) treatment including a taxane and trastuzumab (Herceptin) and there is cancer remaining in the tissue removed during surgery. Patients are selected for therapy based on an FDA-approved test for Kadcyla.

 

Kadcyla is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body. Patients are selected for therapy based on an FDA-approved test for Kadcyla.

 

Important Safety Information

Most important safety information about Kadcyla

Liver problems

• Kadcyla may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching. 

Heart problems

• Kadcyla may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness, or irregular heartbeat.

Pregnancy

• Receiving Kadcyla during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while receiving Kadcyla and for seven months after a patient’s last dose of Kadcyla.
• If a patient thinks she may be pregnant, she should contact her healthcare provider immediately.
• If a patient is exposed to Kadcyla during pregnancy or becomes pregnant within seven months following her last dose of Kadcyla, she is encouraged to report Kadcyla exposure to Genentech by calling (888) 835-2555.
• If a male patient has a female partner that could become pregnant, birth control should be used during treatment and for four months following his last dose of Kadcyla.
• A patient should not breastfeed during treatment and for seven months after the last dose of Kadcyla.

A patient should contact their doctor right away if they experience symptoms associated with these side effects.

 

Additional possible serious side effects of Kadcyla

Lung problems

• Kadcyla may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs.

Infusion-related reactions

• Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. A patient’s doctor will monitor the patient for infusion-related reactions.

Serious bleeding

• Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other medications used to thin the blood (antiplatelet) or prevent blood clots (anticoagulation) can increase the risk of bleeding. A patient’s doctor should provide additional monitoring if the patient is taking one of these other drugs while on Kadcyla. Even when blood thinners are not also being taken, life-threatening bleeding may occur with Kadcyla.

Low platelet count

• Low platelet count may happen during treatment with Kadcyla. Platelets help the blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms.

Nerve damage

• Symptoms of nerve damage may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, muscle weakness, or loss of muscle function.

Skin reactions around the infusion site

• Kadcyla may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion.

 

Most common side effects of Kadcyla

The most common side effects seen in people taking Kadcyla for early breast cancer are:

• Tiredness
• Nausea
• Liver problems
• Pain that affects the bones, muscles, ligaments, and tendons
• Bleeding
• Low platelet count
• Headache
• Weakness, numbness, and pain in the hands and feet
• Joint pain

 

The most common side effects seen in people taking Kadcyla for metastatic breast cancer are:

• Tiredness
• Nausea
• Pain that affects the bones, muscles, ligaments, and tendons
• Bleeding
• Low platelet count
• Headache
• Liver problems
• Constipation
• Nosebleeds

 

Patients are encouraged to report side effects to Genentech and the FDA. Patients may contact Genentech by calling (888) 835-2555. Patients may contact the FDA by visiting http://www.fda.gov/medwatch or calling (800) FDA-1088.

 

Please click here for Kadcyla full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information.

 

Columvi U.S. Indication 

Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer. 

 

It is not known if Columvi is safe and effective in children. 

 

The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works. 

 

What is the most important information I should know about Columvi? 

Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death. 

 

Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including: 

• fever of 100.4°F (38°C) or higher 
• chills or shaking 
• fast or irregular heartbeat 
• dizziness or light-headedness  
• trouble breathing 
• shortness of breath 

 

Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”. 

• A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).  
• You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller “step-up” doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose. 
• You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2). 
• If your dose of Columvi is delayed for any reason, you may need to repeat the “step-up dosing schedule”.  
• If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi. 
• Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions. 

 

Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects. 

 

Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.  

 

What are the possible side effects of Columvi? 

Columvi may cause serious side effects, including:        

• Cytokine Release Syndrome.  
• Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: 
• headache 
• confusion and disorientation  
• difficulty paying attention or understanding things 
• trouble speaking  
• sleepiness 
• memory problems 
• numbness, tingling, or weakness of the hands or feet 
• dizziness 
• shaking (tremors) 
• Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat. 
• Growth in your tumor or worsening of tumor related problems (tumor flare).

Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:   

• tender or swollen lymph nodes 
• pain or swelling at the site of the tumor 
• chest pain 
• cough 
• trouble breathing 

The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness. 

 

The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).  

 

Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.  

 

Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you: 

• have an infection 
• have kidney problems 
• are pregnant or plan to become pregnant. Columvi may harm your unborn baby 
• Females who are able to become pregnant: 
• Your healthcare provider should do a pregnancy test before you start treatment with Columvi.  
• You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi. 
• are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.    

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

 

What should I avoid while receiving Columvi? 

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. 

 

These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.   

 

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. 

 

Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com 

 

What are Tecentriq and Tecentriq Hybreza?

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

 

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

• Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment 
• Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
• has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide.

 

Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer:

• has spread or cannot be removed by surgery, and
• you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer.

 

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer:

• to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and
• small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you.

 

It is not known if Tecentriq Hybreza is safe and effective when used:

• in children for the treatment of SCLC, HCC, or MIBC.

 

It is not known if Tecentriq is safe and effective when used:

• in children for the treatment of SCLC, HCC, or MIBC.

 

Important Safety Information

Who should not receive Tecentriq Hybreza?                                          

Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza

 

What is the most important information about Tecentriq and Tecentriq Hybreza?

Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

 

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: 

Lung problems

• cough
• shortness of breath  
• chest pain 

Intestinal problems  

• diarrhea (loose stools) or more frequent bowel movements than usual 
• stools that are black, tarry, sticky, or have blood or mucus 
• severe stomach-area (abdomen) pain or tenderness 

Liver problems 

• yellowing of your skin or the whites of your eyes 
• severe nausea or vomiting 
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored) 
• bleeding or bruising more easily than normal 

Hormone gland problems

• headaches that will not go away or unusual headaches 
• eye sensitivity to light 
• eye problems 
• rapid heartbeat 
• increased sweating 
• extreme tiredness 
• weight gain or weight loss 
• feeling more hungry or thirsty than usual 
• urinating more often than usual 
• hair loss 
• feeling cold 
• constipation 
• your voice gets deeper 
• dizziness or fainting 
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness 

Kidney problems 

• decrease in your amount of urine 
• blood in your urine
• swelling of your ankles 
• loss of appetite 

Skin problems  

• rash 
• itching 
• skin blistering or peeling     
• painful sores or ulcers in your mouth or your nose, throat, or genital area 
• fever or flu-like symptoms 
• swollen lymph nodes 

 

 

Problems can also happen in other organs. 

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising                     

 

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: 

• chills or shaking 
• itching or rash 
• flushing 
• shortness of breath or wheezing
• dizziness 
• feeling like passing out 
• fever 
• back or neck pain 

 

 

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

 

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications. 

 

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects.

 

Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ or tissue transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant:
• Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza.
• You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.
• are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

The most common side effects of Tecentriq when used alone include:

• feeling tired or weak
• decreased appetite
• nausea
• cough
• shortness of breath

The most common side effects of Tecentriq Hybreza when used alone include:

• feeling tired or weak
• muscle or bone pain
• Cough
• shortness of breath
• decreased appetite

 

The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

 

The most common side effects of Tecentriq and Tecentriq Hybreza when used in hepatocellular carcinoma (HCC) with bevacizumab include:

• high blood pressure
• feeling tired or weak
• too much protein in the urine 

 

The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is:

• urinary tract infection

 

Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

 

These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza.

 

You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

 

Please see full Prescribing Information for Tecentriq and Tecentriq Hybreza and the Medication Guides for Tecentriq and Tecentriq Hybreza for additional Important Safety Information.

 

About Genentech Oncology 

For more than 30 years, Genentech has pioneered oncology breakthroughs and is working to build a future where people with cancer can thrive, in spite of their diagnosis. With our therapies, we are intercepting disease where there is potential to deliver the best outcomes, while striving for longer-term impact in hard-to-treat settings. Our therapies are designed for the real world—reducing treatment burden and ensuring innovative care reaches patients who need them most, wherever they are. By working in lockstep with the medical, scientific, and patient communities, we are shaping the next era of cancer care.

 

About Genentech 

Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. 

 

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