logo
Share SHARE
FONT-SIZE Plus   Neg

Genentech's Perjeta Regimen Gets Priority Review For HER2-Positive Breast Cancer

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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
British lender Lloyds Banking Group Plc. Friday reported higher profit in its first half, benefited by increased net interest income and margin as well as lower impairment. Looking ahead, the company lifted its net interest margin forecast. Amgen reported an increase in second-quarter profit, driven by sales of arthritis drug Enbrel and osteoporosis treatments Xgeva and Prolia, and improved margins. Both earnings and sales topped Wall Street estimates. Electronic Arts Inc. (EA) on Thursday reported an increase in profit for the first quarter, reflecting continued strong digital revenues, with both earnings and revenues topping Wall Street estimates. However, shares of the company fell over 4 percent, after having detailed a weak outlook. Redwood...
comments powered by Disqus
Follow RTT