Monday, Jul 1, 2013
South San Francisco, Calif. -- July 1, 2013 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for the use of a Perjeta® (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer. The FDA has granted a Priority Review of the application and will make a decision on approval by October 31, 2013.
"The impact of treatment in breast cancer is greatest in the early stage, before the cancer has spread to other parts of the body," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We look forward to working with the FDA to bring this potential option to people with HER2-positive early stage breast cancer as soon as possible."
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 easier to surgically remove, or to allow for breast-conserving surgery. There are currently no FDA-approved neoadjuvant treatments for cancer. A common measure of neoadjuvant treatment effect in breast cancer is pathological complete response (pCR), which means there is no tumor tissue detectable at the time of surgery. Perjeta is already approved in the United States and Europe for people with HER2-positive metastatic breast cancer, an advanced form of the disease.
Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers. The combination of Perjeta, Herceptin® and docetaxel chemotherapy is thought to provide a more comprehensive blockade of HER signaling pathways.
A Priority Review designation is granted to medicines that the FDA believes have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The application is based primarily on 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 HER2-positive metastatic breast cancer.
About the NEOSPHERE Study
The NEOSPHERE study (Neoadjuvant Study of Pertuzumab and Herceptin in anEarlyRegimenEvaluation) is a randomized, multicenter, international Phase II study that was conducted in 417 people with newly diagnosed HER2-positive, locally advanced, inflammatory or early stage breast cancer. Participants were randomized to four study arms and received four cycles (12 weeks) of neoadjuvant treatment. The primary endpoint was pCR. Secondary endpoints included clinical response, time to clinical response, safety profile, disease-free survival (DFS), breast-conserving surgery rate and biomarker assessment. Study data showed the following:
About the TRYPHAENA Study
The TRYPHAENA study (ToleRabilitY ofPertuzumab,Herceptin andAnthracyclinEs inNeoAdjuvant breast cancer) is a randomized, multicenter Phase II study that was conducted in 225 people with HER2-positive, locally advanced, inflammatory or early stage breast cancer. Participants were randomized to one of three neoadjuvant Perjeta regimens. The primary endpoint was cardiac safety. Secondary endpoints included pCR, clinical response, breast-conserving surgery rate, DFS, progression-free survival (PFS), overall survival (OS) and biomarker assessment. Study data showed the following:
The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin and standard regimens of adjuvant chemotherapy with Herceptin and standard regimens of adjuvant chemotherapy in people with HER2-positive early stage breast cancer. The study will enroll approximately 4,800 people, and the primary endpoint is invasive disease-free survival (IDFS).
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.
About Genentech and Roche in HER2-positive Breast Cancer
Genentech and Roche have spent more than 30 years studying the role of HER2 in cancer, and Perjeta is a result of this research. A companion diagnostic test is used to determine if a person is HER2-positive and whether treatment with Perjeta and Herceptin is appropriate.
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 http://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 http://www.perjeta.com.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 235,000 people in the United States will be diagnosed with breast cancer, and 40,000 will die from the disease in 2013. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as "HER2 positivity" and affects approximately 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.
Founded more than 30 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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