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

Editors Pick
Internet giant Google Inc. (GOOGL, GOOG) has launched a new online flight search tool that makes it easy to find out the best flight deal. The tool dubbed "Google Flights" provides a calendar that one can scroll through and see the lowest fare highlighted for each day. One can also use the lowest... Hyperloop Transportation Technologies, a start-up that has adopted Elon Musk's ambitious project of high-speed transportation system, plans to build a Hyperloop test track in California and completed as early as 2016. Hyperloop Test Technologies, a crowd-funded company, plans to take Musk's dream... Colors have set the social media afire after an otherwise innocuous photo of a bodycon dress kept users guessing as to what hues permeate it. Opinions are divided, with some seeing the dress as white and gold, and others as blue and black. The photo was posted on Tumblr by a user called Swiked.
comments powered by Disqus
Follow RTT