Thursday, Nov 1, 2018

Genentech to Present New Data From Its Industry-Leading Hematology Portfolio at the American Society of Hematology (ASH) 2018 Annual Meeting

Ten medicines featured in over 70 abstracts, including 25 oral presentations

Additional data from three pivotal studies of Hemlibra in people with hemophilia A, with or without factor VIII inhibitors

Updated data from three pivotal studies of Venclexta in chronic lymphocytic leukemia and acute myeloid leukemia

First clinical data for two novel T-cell engaging bispecific antibodies in non-Hodgkin’s lymphoma

South San Francisco, CA -- November 1, 2018 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data for its approved and investigational medicines across a range of blood diseases, and including several first-in-class medicines, will be presented at the 60^th American Society of Hematology (ASH) Annual Meeting from December 1-4 in San Diego. Ten Genentech medicines will be featured in more than 70 abstracts, including 25 oral presentations, across 15 blood diseases.

“We look forward to sharing progress from our broad development program in hematology at ASH this year, reflecting our approach to understand mechanisms of blood diseases at the molecular level,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are excited to be presenting data across multiple blood diseases, including studies of several first-in-class medicines with the potential to transform standards of care and improve patients’ lives.”

Hemlibra^® (emicizumab-kxwh), which represents the first new class of medicine in nearly 20 years for people with hemophilia A, will be featured in 12 abstracts at the congress. New data in children younger than 12 with hemophilia A with and without factor VIII inhibitors will be presented, including the full results from the pivotal HAVEN 2 study evaluating three different Hemlibra dosing options (once weekly, every two weeks or every four weeks) in children with hemophilia A with factor VIII inhibitors. Additionally, treatment preference data from the pivotal HAVEN 3 study in people with hemophilia A without factor VIII inhibitors and the pivotal HAVEN 4 study in people with hemophilia A with and without factor VIII inhibitors will be presented. Hemlibra was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A without factor VIII inhibitors and is the only hemophilia treatment that can be administered subcutaneously and at multiple dosing options for all people with hemophilia A, with and without factor VIII inhibitors.

Genentech will also share data for medicines for a range of blood cancers, across multiple lines of treatment. Highlights include updated results from the Phase III MURANO study evaluating Venclexta^® (venetoclax) in chronic lymphocytic leukemia (CLL). In addition, data evaluating Venclexta in acute myeloid leukemia (AML) will be featured, including two Phase Ib/II combination studies (M14-358 study and M14-387 study). Venclexta was recently approved in the United States as a treatment for relapsed or refractory CLL, and is currently under review by the FDA for the treatment of previously untreated AML in combination with a hypomethylating agent or in combination with low dose cytarabine, with a decision expected by end of year. Venclexta is being developed by AbbVie and Genentech.

Updated efficacy data from the Phase II GO29365 study evaluating polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate, in combination with Rituxan^® (rituximab) plus bendamustine, in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), will also be presented. The results of the DLBCL portion of the GO29365 study will be submitted to health authorities around the world for approval consideration. Data from the Phase III GALLIUM study of Gazyva^® (obinutuzumab) in previously untreated follicular lymphoma which support the prognostic value of minimal residual disease status at the end of induction treatment will also be presented.

Finally, Genentech will present early data for two novel T-cell engaging bispecific antibodies in non-Hodgkin’s lymphoma (NHL), which includes initial efficacy and safety results from the first clinical trials for the investigational medicines mosunetuzumab and CD20-TCB. These bispecific antibodies redirect T-cells to engage and eliminate malignant B-cells. This builds on Genentech’s extensive history and expertise in the development of anti-CD20 antibodies for the treatment of numerous B-cell malignancies.

Key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.

Follow Genentech on Twitter via @Genentech and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH18.

Medicine	Abstract title	Abstract number /Presentation details
Hemlibra (approved use; updated study results)	Emicizumab Prophylaxis Provides Flexible and Effective Bleed Control in Children with Hemophilia A with Inhibitors: Results from the HAVEN 2 Study	#632 Oral presentation (session 322) Dec. 3, 2018 10:45 AM PT
	Immunogenicity of Emicizumab in People with Hemophilia A (PwHA): Results from the HAVEN 1-4 Studies	#633 Oral presentation (session 322) Dec. 3, 2018 11:00 AM PT
	Preference for Emicizumab Over Prior Factor Treatments: Results from the HAVEN 3 and HAVEN 4 Studies	#1187 Poster presentation (session 322) Dec. 1, 2018 6:15 – 8:15 PM PT
	Every 2 Weeks or Every 4 Weeks Subcutaneous Injection of Emicizumab in Pediatric Patients with Severe Hemophilia A Without Inhibitors: A Multi-Center, Open-Label Study in Japan (HOHOEMI Study)	#1186 Poster presentation (session 322) Dec. 1, 2018 6:15 – 8:15 PM PT
Venclexta (approved use; updated study results)	First Prospective Data on Impact of Minimal Residual Disease on Long-term Clinical Outcomes after Venetoclax plus Rituximab versus Bendamustine plus Rituximab: Phase III MURANO Study	#695 Oral presentation (session 642) Dec. 3, 2018 11:30 AM PT
	MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) Chronic Lymphocytic Leukemia (CLL)	#184 Oral presentation (session 642) Dec. 1, 2018 2:45 PM PT
Venclexta (investigational)	Venetoclax in combination with hypomethylating agents induces rapid, deep, and durable responses in patients with AML ineligible for intensive therapy	#285 Oral presentation (session 615) Dec. 2, 2018 8:00 AM PT
	Venetoclax with low-dose cytarabine induces rapid, deep, and durable responses in previously untreated older adults with AML ineligible for intensive chemotherapy	#284 Oral presentation (session 615) Dec. 2, 2018 7:45 AM PT
Polatuzumab vedotin (investigational)	Polatuzumab Vedotin (Pola) Plus Bendamustine (B) with Rituximab (R) or Obinutuzumab (G) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results of a Phase (Ph) Ib/II Study	#1683 Poster presentation (session 626) Dec. 1, 2018 6:15 – 8:15 PM PT
Gazyva (approved use)	Minimal Residual Disease Response at End of Induction and During Maintenance Correlates with Updated Outcome in the Phase III GALLIUM Study of Obinutuzumab- or Rituximab-Based Immunochemotherapy in Previously Untreated Follicular Lymphoma Patients	#396 Oral presentation (session 623) Dec. 2, 2018 1:15 PM PT
Mosunetuzumab (investigational)	Mosunetuzumab, a Full-Length Bispecific CD20/CD3 Antibody, Displays Clinical Activity in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL): Interim Safety and Efficacy Results from a Phase 1 Study	#399 Oral presentation (session 626) Dec. 2, 2018 12:30 PM PT
CD20-TCB (investigational)	CD20-Tcb (RG6026), a Novel “2:1” Format T-Cell-Engaging Bispecific Antibody, Induces Complete Remissions in Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma: Preliminary Results from a Phase I First in Human Trial	#226 Oral presentation (session 626) Dec. 1, 2018 4:45 PM PT

Hemlibra Indication

Hemlibra is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

Important Safety Information

What is the most important information to know about Hemlibra? 

Hemlibra increases the potential for blood to clot. Patients should carefully follow their healthcare provider’s instructions regarding when to use an on-demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. Hemlibra may cause the following serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA^®), including: 

• Thrombotic microangiopathy (TMA).  This is a condition involving blood clots and injury to small blood vessels that may cause harm to one's kidneys, brain, and other organs. Patients should get medical help right away if they have any of the following signs or symptoms during or after treatment with Hemlibra:
  • confusion
  • weakness
  • swelling of arms and legs
  • yellowing of skin and eyes
  • stomach (abdomen) or back pain
  • nausea or vomiting
  • feeling sick
  • decreased urination
• Blood clots (thrombotic events).  Blood clots may form in blood vessels in the arm, leg, lung, or head. Patients should get medical help right away if they have any of these signs or symptoms of blood clots during or after treatment with Hemlibra:
  • swelling in arms or legs
  • pain or redness in the arms or legs
  • shortness of breath
  • chest pain or tightness
  • fast heart rate
  • cough up blood
  • feel faint
  • headache
  • numbness in the face
  • eye pain or swelling
  • trouble seeing

If aPCC (FEIBA^®) is needed, patients should talk to their healthcare provider in case they feel they need more than 100 U/kg of aPCC (FEIBA^®) total. 

Before using Hemlibra, patients should tell their healthcare provider about all of their medical conditions, including if they: 

• are pregnant or plan to become pregnant. It is not known if Hemlibra may harm an unborn baby. Females who are able to become pregnant should use birth control (contraception) during treatment with Hemlibra.
• are breastfeeding or plan to breastfeed. It is not known if Hemlibra passes into breast milk.

Patients should tell their healthcare provider about all the medicines they take,  including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Patients should keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

How should patients use Hemlibra?

Patients should see the detailed “Instructions for Use” that comes with Hemlibra for information on how to prepare and inject a dose of Hemlibra, and how to properly throw away (dispose of) used needles and syringes. 

•  Stop (discontinue) prophylactic use of bypassing agents the day before starting Hemlibra prophylaxis. 
•  Patients may continue prophylactic use of factor VIII for the first week of Hemlibra prophylaxis. 

What should patients know about lab monitoring?

Hemlibra may interfere with laboratory tests that measure how well blood is clotting and may cause a false reading. Patients should talk to their healthcare provider about how this may affect their care.

The most common side effects of Hemlibra include:  redness, tenderness, warmth, or itching at the site of injection; headache; and joint pain.

These are not all of the possible side effects of Hemlibra. Patients should speak to their healthcare provider for medical advice about side effects.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Patients should not use Hemlibra for a condition for which it was not prescribed. Patients should not give Hemlibra to other people, even if they have the same symptoms that they have. It may harm them. Patients can ask their pharmacist or healthcare provider for information about Hemlibra that is written for health professionals.

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

Please see the Hemlibra full  Prescribing Information  and  Medication Guide  for more important safety information including Serious Side Effects.

Venclexta Indication

Venclexta is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.

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

Important Safety Information: 

Venclexta can cause serious side effects, including:

Tumor lysis syndrome (TLS).  TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. A patient’s doctor will do tests for TLS. It is important for patients taking Venclexta to keep their appointments for blood tests. Patients will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. Patients may also need to receive intravenous (IV) fluids into their vein. Patients taking Venclexta must tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Patients should drink plenty of water when taking Venclexta  to help reduce the risk of getting TLS.
Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before their first dose, on the day of their first dose of Venclexta, and each time the dose is increased.

Certain medicines must not be taken when patients first start taking Venclexta and while their dose is being slowly increased because of the risk of increased tumor lysis syndrome. 

• Patients must tell their doctor about all the medicines they take,  including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other, causing serious side effects.
• Patients must not start new medicines during treatment with Venclexta without first talking with their doctor.

 Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they: 

• Have kidney or liver problems.
• Have problems with their body salts or electrolytes, such as potassium, phosphorus, or calcium.
• Have a history of high uric acid levels in their blood or gout.
• Are scheduled to receive a vaccine. Patients should not receive a “live vaccine” before, during, or after treatment with Venclexta until their doctor tells them it is okay. If a patient is not sure about the type of immunization or vaccine, they should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta.
• Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If a patient is able to become pregnant, the doctor should do a pregnancy test before they start treatment with Venclexta, and they should use effective birth control during treatment and for 30 days after the last dose of Venclexta.
• Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into breast milk. Patients should not breastfeed during treatment with Venclexta.

Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood.

Venclexta can cause serious side effects, including:

• Low white blood cell count (neutropenia).  Low white blood cell counts are common with Venclexta but can also be severe. A doctor will do blood tests to check a patient’s blood counts during treatment with Venclexta. Patients must tell their doctor right away if they have a fever or any signs of an infection.

The most common side effects of Venclexta when used in combination with rituximab include  low white blood cell count, diarrhea, upper respiratory tract infection, cough, tiredness, and nausea.

The most common side effects of Venclexta when used alone include  low white blood cell count, diarrhea, nausea, upper respiratory tract infection, low red blood cell count, tiredness, low platelet count, muscle and joint pain, swelling of the arms, legs, hands, and feet, and cough.

Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.

These are not all the possible side effects of Venclexta. Patients must tell their doctor if they have any side effect that bothers them or that does not go away.

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

Please visit http://www.Venclexta.com for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information. 

Rituxan Indications

Rituxan^® (rituximab) injection, for intravenous use, is indicated for the treatment of patients with:

• Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
• Follicular CD20-positive non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
• Low-grade CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
• CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
• CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

Important Safety Information: 

Rituxan can cause serious side effects that can lead to death, including:

• Infusion Reactions:  Infusion reactions are very common side effects of Rituxan treatment. Serious infusion reactions can happen during the patient’s infusion or within 24 hours after the patient’s infusion of Rituxan. The patient’s doctor should give the patient medicines before infusion of Rituxan to decrease the chance of having a severe infusion reaction.

Patients must tell their doctor or get medical help right away about any of these symptoms during or after an infusion of Rituxan:

• Hives (red itchy welts) or rash
• Itching
• Swelling of the lips, tongue, throat, or face
• Sudden cough
• Shortness of breath, difficulty breathing, or wheezing
• Weakness
• Dizziness or feel faint
• Palpitations (feel like the heart is racing or fluttering)
• Chest pain
• Severe Skin and Mouth Reactions:  Patients must tell their doctor or get medical help right away about any of these symptoms at any time during treatment with Rituxan:
  • Painful sores or ulcers on the skin, lips, or in the mouth
  • Blisters
  • Peeling skin
  • Rash
  • Pustules
• Hepatitis B Virus (HBV) Reactivation:  Before receiving Rituxan treatment, the patient’s doctor will do blood tests to check for HBV infection. If the patient has had hepatitis B or is a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure, and death. The patient’s doctor will monitor for hepatitis B infection during and for several months after the patient stops receiving Rituxan.

Patients must tell their doctor right away about worsening tiredness, or yellowing of the skin or white part of the eyes during treatment with Rituxan.

• Progressive Multifocal Leukoencephalopathy (PML):  PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.

Patients must tell their doctor right away about new or worsening symptoms or if anyone close to the patient notices these symptoms:

• Confusion
• Dizziness or loss of balance
• Difficulty walking or talking
• Decreased strength or weakness on one side of the body
• Vision problems, such as blurred vision or loss of vision

What should patients tell their doctor before receiving Rituxan? 

Before receiving Rituxan, patients should tell their doctor if they:

• Have had a severe reaction to Rituxan or a rituximab product
• Have a history of heart problems, irregular heartbeat, or chest pain
• Have lung or kidney problems
• Have had an infection, currently have an infection, or have a weakened immune system
• Have or have had any severe infections including:
  • Hepatitis B virus (HBV)
  • Hepatitis C virus (HCV)
  • Cytomegalovirus (CMV)
  • Herpes simplex virus (HSV)
  • Parvovirus B19
  • Varicella zoster virus (chickenpox or shingles)
  • West Nile Virus
• Have had a recent vaccination or are scheduled to receive vaccinations. Patients should not receive certain vaccines before or during treatment with Rituxan
• Have any other medical conditions
• Are pregnant or plan to become pregnant. Patients must talk to their doctor about the risks to the patient’s unborn baby if receiving Rituxan during pregnancy. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rituxan and for 12 months after the last dose of Rituxan. Patients should talk to their doctor about effective birth control. Patients should tell their doctor right away if they become pregnant or think that they are pregnant during treatment with Rituxan
• Are breastfeeding or plan to breastfeed. It is not known if Rituxan passes into the breast milk. Do not breastfeed during treatment and for at least 6 months after the last dose of Rituxan
• Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements
• What are the possible side effects of  Rituxan? 

Rituxan can cause serious side effects, including:

• Tumor Lysis Syndrome (TLS):  TLS is caused by the fast breakdown of cancer cells. TLS can cause the patient to have:
  • Kidney failure and the need for dialysis treatment
  • Abnormal heart rhythm

TLS can happen within 12 to 24 hours after an infusion of Rituxan. The patient’s doctor may do blood tests to check for TLS. The patient’s doctor may give medicine to help prevent TLS. Patients must tell their doctor right away if they have any of the following signs or symptoms of TLS:

• Nausea
• Vomiting
• Diarrhea
• Lack of energy

• Serious Infections:  Serious infections can happen during and after treatment with Rituxan, and can lead to death. Rituxan can increase the patient’s risk of getting infections and can lower the ability of the patient’s immune system to fight infections. Types of serious infections that can happen with Rituxan include bacterial, fungal, and viral infections. After receiving Rituxan, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive Rituxan. Patients must tell their doctor right away if they have any symptoms of infection:
  • Fever
  • Cold symptoms, such as runny nose or sore throat that do not go away
  • Flu symptoms, such as cough, tiredness, and body aches
  • Earache or headache
  • Pain during urination
  • Cold sores in the mouth or throat
  • Cuts, scrapes, or incisions that are red, warm, swollen, or painful
• Heart Problems:  Rituxan may cause chest pain, irregular heartbeats, and heart attack. The patient’s doctor may monitor the patient’s heart during and after treatment with Rituxan if they have symptoms of heart problems or have a history of heart problems. Patients must tell their doctor right away if they have chest pain or irregular heartbeats during treatment with Rituxan.
• Kidney Problems:  especially if the patient is receiving Rituxan for NHL. Rituxan can cause severe kidney problems that lead to death. The patient’s doctor should do blood tests to check how well their kidneys are working.
•  Stomach and Serious Bowel Problems That Can Sometimes Lead to Death:  Bowel problems, including blockage or tears in the bowel can happen if the patient receives Rituxan with chemotherapy medicines. Patients must tell their doctor right away if they have any stomach-area (abdomen) pain or repeated vomiting during treatment with Rituxan.

 The patient’s doctor will stop treatment with Rituxan if they have severe, serious, or life-threatening side effects. 

 What are the most common side effects during treatment with Rituxan? 

• Infusion-related reactions
• Infections (may include fever, chills)
• Body aches
• Tiredness
• Nausea

Other side effects include:

• Aching joints during or within hours of receiving an infusion
• More frequent upper respiratory tract infections

These are not all of the possible side effects with Rituxan.

Please see the Rituxan full Prescribing Information, including the Medication Guide, for additional Important Safety Information at http://www.Rituxan.com.

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

Gazyva Indications

 Gazyva^® (obinutuzumab) is a prescription medicine used:

• With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
• With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.
• With chemotherapy, followed by Gazyva alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment.

Important Safety Information

The most important safety information patients should know about Gazyva 

Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that can become serious or life threatening, including:

• Hepatitis B Virus (HBV):  Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive Gazyva:

Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that may become severe or life threatening, including:

• Infusion Reactions:  These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is life threatening, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Symptoms of infusion reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
• Hypersensitivity Reactions Including Serum Sickness: Some patients receiving Gazyva may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue Gazyva
• Tumor Lysis Syndrome (TLS):  Tumor lysis syndrome, including fatal cases, has been reported in patients receiving Gazyva. Gazyva works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness
• Infections: While the patient is taking Gazyva, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered Gazyva in combination with chemotherapy, followed by Gazyva alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with Gazyva. Patients taking Gazyva plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking Gazyva plus CHOP or CVP
• Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with Gazyva. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections
• Low Platelet Count : Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking Gazyva, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with Gazyva. Fatal bleeding events have occurred in patients treated with Gazyva. If the patient’s platelet count gets too low, their treatment may be delayed or reduced

The most common side effects of Gazyva in CLL were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea

The safety of Gazyva was evaluated based on 392 patients with relapsed or refractory NHL, including FL (81 percent), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which Gazyva is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of side effects that were seen were consistent with the overall population who had NHL. The most common side effects of Gazyva were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness and urinary tract infection

A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of Gazyva as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%). The most common side effects of Gazyva were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea

 Before receiving Gazyva, patients should talk to their doctor about: 

• Immunizations: Before receiving Gazyva therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines
• Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. Gazyva may harm their unborn baby. The patient should speak to their doctor about using Gazyva while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received Gazyva during pregnancy. It is not known if Gazyva may pass into the patient’s breast milk. The patient should speak to their doctor about using Gazyva if they are breastfeeding

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

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

Please visit http://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information. 

About Genentech in Hematology 

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.

About Genentech 
Founded more than 40 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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