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
Xiaomi Corp., nicknamed the "Apple of China" is planning to launch laptops, a report by Bloomberg said. The Chinese brand has been pausing a direct challenge to major smart phone brands in Asian markets in the recent years. It has planned to win over China, India and Brazil markets those together would account for one third of the worldwide sales. Value-priced fashion apparel and accessories retailer Cato Corp. (CATO) Thursday announced a four percent increase in comparable store sales for August. Sales were for the four week period was up five percent to $67 percent from $63.6 million last year. For the thirty weeks ended August 29, the... Simple, uncluttered, colorful and friendly. That's how Google describes its new logo. The new typeface is sans-serif and without any shadow or embossing, unlike its earlier logos. It has given blue, red, yellow and green to its letters. The "e" is slightly tilted and stylized. On its browser tabs, it has replaced the lower case blue colored "g" with an upper case "G" in four colors.
comments powered by Disqus
Follow RTT