FDA Advisory Committee to review Genentech’s Perjeta regimen for use before surgery in HER2-positive early stage breast cancer

South San Francisco, Calif. — August 8th, 2013 — Genentech today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will discuss the company's application for use of a Perjeta®(pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer. The advisory committee meeting will take place on September 12, 2013.

“We support the FDA’s efforts to bring promising medicines to people with early stage breast cancer more quickly,” said Sandra Horning, M.D., global head, Clinical Development Hematology/Oncology. “We look forward to discussing our Perjeta application with the committee.”

The Perjeta neoadjuvant application is based primarily on positive results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in previously untreated HER2-positive metastatic breast cancer. The application utilizes a proposed new FDA pathway for the accelerated approval of neoadjuvant treatments in early stage breast cancer, which is designed to help bring promising medicines to people with earlier stages of breast cancer faster. The FDA has granted a Priority Review of the Perjeta neoadjuvant application and will make a decision on approval by October 31, 2013. Perjeta is already approved in the United States and Europe for people with previously untreated HER2-positive metastatic breast cancer, an advanced and aggressive form of the disease.

About Neoadjuvant Treatment

Neoadjuvant therapy is a treatment option given after diagnosis but before surgery for early stage breast cancer (cancer that has not spread beyond the breast or lymph nodes). Neoadjuvant treatment aims to reduce a tumor’s size so it may be more easily removed by surgery, or to allow for breast-conserving surgery. Neoadjuvant treatment may also enable a doctor to more quickly assess whether a treatment is active in fighting a person’s early stage breast cancer.

About Perjeta

Perjeta is a medicine that targets the HER2 receptor, a protein found 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^&reg are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta, Herceptin and docetaxel chemotherapy is thought to provide a more comprehensive blockade of HER signaling pathways.

Perjeta Indication Statement

Perjeta^&reg (pertuzumab) is approved for use in combination with Herceptin^&reg (trastuzumab) and docetaxel chemotherapy in people with 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 disease.

Important Safety Information

• Because side effects from this treatment are common, it is important to know what side effects may happen and what symptoms patients should watch for.
• A patient’s doctor may stop treatment if serious side effects happen. Patients must contact their healthcare team right away if they have questions or are worried about any side effects.

Most Serious Side Effect of 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 six months after a patient’s last dose of Perjeta. Patients who are breastfeeding should talk with their doctor about either stopping breastfeeding or stopping treatment with Perjeta.
• If a patient thinks she may be pregnant, she should contact her healthcare provider immediately.
• If a patient is exposed to Perjeta during pregnancy, she is encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720.

Other Possible Serious Side Effects

• Heart problems: Perjeta can result in 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.
• 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 chemotherapy were feeling tired, abnormal or altered taste, allergic reactions, muscle pain and vomiting.
• Severe allergic reactions: Some people receiving Perjeta may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly and may affect many areas of the body.

Perjeta has been shown to work only in people with HER2-positive breast cancer. Patients must have a HER2 test to know if their breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as Perjeta.

Most Common Side Effects

The most common side effects of Perjeta when given with Herceptin and docetaxel chemotherapy are:

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

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

Please see Perjeta full Prescribing Information including Most Serious Side Effect for additional Important Safety Information at www.perjeta.com.

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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.