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.
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® 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® (pertuzumab) is approved for use in combination with Herceptin® (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
Most Serious Side Effect of Perjeta
Receiving Perjeta during pregnancy can result in the death of an unborn baby and birth defects.
Other Possible Serious Side Effects
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:
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.
Founded 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.