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Wednesday, Dec 20, 2017

FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer

Accelerated approval of Perjeta for neoadjuvant use also converted to full approval

South San Francisco, CA -- December 20, 2017 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.

“The goal of treating breast cancer early is to provide people with the best chance for a cure. While we come closer to this goal with each advance, many people still have a recurrence and progress to the metastatic stage,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Today’s approval of Perjeta means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning.”

The FDA-approved use of the Perjeta-based regimen for adjuvant treatment of HER2-positive EBC at high risk of recurrence is based on results of the Phase III APHINITY study. At the time of the primary analysis with a median of 45.4 months follow-up:

  • In the overall study population, Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18 percent compared to Herceptin and chemotherapy alone (HR=0.82, 95% CI 0.67-1.00, p=0.047).
  • High-risk patients included patients such as those with lymph node-positive or hormone receptor-negative breast cancer. The subgroup results were as follows:
    • Lymph node-positive subgroup (HR=0.77, 95% CI 0.62-0.96)
    • Hormone receptor-negative subgroup (HR=0.76, 95% CI 0.56-1.04)
    • Hormone receptor-positive subgroup (HR=0.86, 95% CI 0.66-1.13)
    • Lymph node-negative subgroup (HR=1.13, 95% CI 0.68-1.86)

The most common severe (Grade 3-4) side effects with the Perjeta-based regimen are low levels of white blood cells with or without a fever, diarrhea, decrease in certain types of white blood cells, decrease in red blood cells, fatigue, nausea and mouth blisters or sores. The most common side effects are diarrhea, nausea, hair loss, fatigue, nerve damage and vomiting.

The supplemental Biologics License Application for the Perjeta-based regimen for adjuvant treatment of HER2-positive EBC was granted Priority Review, a designation given to medicines the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Perjeta is also approved for use in combination with Herceptin and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

For those who qualify, Genentech offers patient assistance programs for people prescribed Perjeta and Herceptin by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit http://www.Genentech-Access.com for more information.

About APHINITY

APHINITY (Adjuvant Pertuzumab andHerceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, Phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as adjuvant therapy in 4,805 people with operable HER2-positive EBC. The primary efficacy endpoint of the APHINITY study is invasive disease-free survival (iDFS), which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.

The following table is a summary of APHINITY study results supporting this approval.

APHINITY Study Results

Median follow-up for intent-to-treat (ITT) population 45.4 months (381 events)

Primary endpoint: invasive disease-free survival (iDFS)

HR=0.82, 95% CI 0.67-1.00, p=0.04 7*

 

Perjeta + Herceptin + chemotherapy
n=2,400

Placebo +
Herceptin + chemotherapy
n=2,404

iDFS at 3 years

ITT population

n=4,804

94.1%

171 events

93.2%

210 events

HR=0.82, 95% CI 0.67-1.00, p=0.047*

Node-positive subgroup

n=3,005

92.0%

139 events

n=1,503

90.2%

181 events

n=1,502

HR=0.77, 95% CI 0.62-0.96

Node-negative subgroup

n=1,799

97.5%

32 events

n=897

98.4%

29 events

n=902

HR=1.13, 95% CI 0.68-1.86

Hormone receptor-positive subgroup

n=3,082

94.8%

100 events

n=1,536

94.4%

119 events

n=1,546

HR=0.86, 95% CI 0.66-1.13

Hormone receptor-negative subgroup
n=1,722

92.8%

71 events

n=864

91.2%

91 events

n=858

HR=0.76, 95% CI 0.56-1.04

Anthracycline chemotherapy subgroup

n=3,742

93.8%

139 events

n=1,865

93.0%

171 events

n=1,877

HR=0.82, 95% CI 0.66-1.03

Non-anthracycline chemotherapy subgroup
n=1,062

94.9%

32 events

n=535

94.0%

39 events

n=527

HR=0.82, 95% CI 0.51-1.31

Safety

Heart failure

0.6%

0.2%

Most common (≥5%) severe (Grade 3-4) adverse events

Neutropenia

Decrease in a certain type of white blood cell

16%

16%

Febrile neutropenia

Fever associated with decrease in a certain type of white blood cell

12%

11%

Diarrhea

10%

4%

Neutrophil count decreased

Decrease in a certain type of white blood cell

10%

10%

Anemia

Decrease in red blood cells

7%

5%

* Analysis stratified by nodal status, protocol version, central hormone receptor status and adjuvant chemotherapy regimen. Stratification factors are defined according to the randomization data for iDFS.

Exploratory analyses without adjusting for multiple comparisons. Results are considered descriptive.

Symptomatic heart failure (New York Heart Association class III or IV) with left ventricular ejection fraction (LVEF) drop ≥10 percent from baseline and to below 50 percent.

About Perjeta

Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerizing’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumor growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signaling pathways, thus preventing tumor cell growth and survival.

Perjeta Indication Statements

Perjeta is approved for use in combination with Herceptin and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Perjeta is approved for use in combination with Herceptin and chemotherapy for:

  • use prior to surgery (neoadjuvant treatment) in people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than two centimeters in diameter or node-positive). Perjeta should be used as part of a complete treatment regimen for early stage breast cancer.
  • use after surgery (adjuvant treatment) in people with HER2-positive early breast cancer that has a high likelihood of coming back.

Important Safety Information

Side effects with Perjeta

  • Not all people have serious side effects; however, side effects with Perjeta therapy are common. It is important to know what side effects may happen and what symptoms a patient should watch for.
  • A patient’s doctor may stop treatment if serious side effects happen. A patient should be sure to contact their healthcare team right away if they have questions or are worried about any side effects.

Most serious side effects

Perjeta may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).

  • A patient’s doctor may run tests to monitor the patient’s heart function before and during treatment with Perjeta.
  • Based on test results, a patient’s doctor may hold or discontinue treatment with Perjeta.

Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.

  • Birth control should be used while receiving Perjeta and for seven months after a patient’s last dose of Perjeta. If a patient is a mother who is breastfeeding, the patient should talk with her doctor about either stopping breastfeeding or stopping Perjeta.
  • If a patient thinks she may be pregnant, the patient should contact her healthcare provider immediately.
  • If a patient is exposed to Perjeta during pregnancy, or becomes pregnant while receiving Perjeta or within seven months following the last dose of Perjeta in combination with Herceptin, the patient is encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720 or visiting http://www.motherpregnancyregistry.com and report Perjeta exposure to Genentech at (888) 835-2555.

Other possible serious side effects

  • Perjeta should not be used in patients who are allergic to pertuzumab or to any of the ingredients in Perjeta.
  • Infusion-related reactions: Perjeta is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving Perjeta, Herceptin and docetaxel were feeling tired, abnormal or altered taste, allergic reactions, muscle pain and vomiting. The most common infusion-related reactions when receiving Perjeta alone were fever, chills, feeling tired, headache, weakness, allergic reactions and vomiting.
  • Severe allergic reactions: Some people receiving Perjeta may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. These reactions may be severe, may happen quickly and may affect many areas of the body.

Most common side effects

The most common side effects of Perjeta when given with Herceptin and docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

  • Diarrhea
  • Hair loss
  • Low levels of white blood cells with or without fever
  • Nausea
  • Feeling tired
  • Rash
  • Damage to the nerves (numbness, tingling, pain in hands/feet)

The most common side effects of Perjeta when given with Herceptin and docetaxel as part of an early breast cancer regimen before surgery are:

  • Hair loss
  • Low levels of white blood cells with or without fever
  • Diarrhea
  • Nausea

The most common side effects of Perjeta when given with Herceptin and docetaxel following three cycles of epirubicin, cyclophosphamide and fluorouracil as part of an early breast cancer regimen before surgery are:

  • Diarrhea
  • Nausea
  • Hair loss
  • Low levels of white blood cells with or without fever
  • Vomiting
  • Feeling tired

The most common side effects of Perjeta when given with Herceptin, docetaxel and carboplatin as part of an early breast cancer regimen before surgery are:

  • Diarrhea
  • Hair loss
  • Low levels of white blood cells with or without fever
  • Nausea
  • Feeling tired
  • Vomiting
  • Low levels of red blood cells
  • Low platelet count

The most common side effects of Perjeta when given with Herceptin and paclitaxel following four cycles of dose-dense doxorubicin and cyclophosphamide as part of an early breast cancer regimen before surgery are:

  • Nausea
  • Diarrhea
  • Hair loss
  • Feeling tired
  • Constipation
  • Damage to the nerves (numbness, tingling, pain in hands/feet)
  • Headache

The most common side effects of Perjeta when given with Herceptin and docetaxel following four cycles of epirubicin, cyclophosphamide and fluorouracil as part of an early breast cancer regimen before surgery are:

  • Diarrhea
  • Nausea
  • Hair loss
  • Weakness
  • Constipation
  • Feeling tired
  • Mouth blisters or sores
  • Vomiting
  • Pain in the muscles
  • Low levels of red blood cells

The most common side effects of Perjeta when given with Herceptin and chemotherapy as part of an early breast cancer regimen after surgery are:

  • Diarrhea
  • Nausea
  • Hair loss
  • Feeling tired
  • Damage to the nerves (numbness, tingling, pain in hands/feet)
  • Vomiting

Patients are encouraged to report side effects to Genentech and the FDA. 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 see the full Prescribing Information for additional Important Safety Information, including most serious side effects, at http://www.perjeta.com.

About Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 255,180 people in the United States will be diagnosed with breast cancer, and 41,070 will die from the disease in 2017. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of tumor cells. This is known as “HER2 positivity” and affects approximately 15-20 percent of people with breast cancer. HER2-positive cancer is an aggressive form of breast cancer.

About Genentech in HER2-positive Breast Cancer

Genentech has spent more than 30 years studying the role of HER2 in cancer, and Perjeta is a result of this research. A diagnostic test is used to determine if a person’s tumor is HER2-positive and whether treatment with HER2-targeted medicines is appropriate.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.4 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.

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 or 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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