Genentech, a member of the Roche Group (RHHBY.PK), reported that the U.S. Food and Drug Administration or FDA has accepted the company's supplemental Biologics License Application or sBLA for the use of a Perjeta regimen before surgery in people with HER2-positive early stage breast cancer. The FDA has granted a Priority Review of the application and would decide on approval by October 31, 2013.
Neoadjuvant therapy, a treatment option given after diagnosis but before surgery for early stage breast cancer, aims to reduce a tumor's size so it may be easier to surgically remove, or to allow for breast-conserving surgery. 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, Genentech added.
A priority review designation is awarded to medicines that the FDA hopes to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The application is based mainly on results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in HER2-positive early stage breast cancer, and on longer-term safety data from the Phase III CLEOPATRA trial of Perjeta in HER2-positive metastatic breast cancer.
The TRYPHAENA study is a randomized, multicenter Phase II trial that was conducted in 225 people with HER2-positive, locally advanced, inflammatory or early stage breast cancer.
by RTT Staff Writer
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