Accelerated FDA Review For HER2-Positive Drug

HER2 positive breast cancer agent granted accelerated FDA review

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) HER2-positive breast cancer is one of the most aggressive forms of the disease. A new treatment option may soon be available to help battle this vicious cancer.

The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted the drug Priority Review as a treatment for advanced HER2-positive breast cancer.

This agent is designed for individuals with locally advanced or metastatic (has spread) HER2-positive breast cancer that has already been treated with Herceptin (trastuzumab) and a taxane chemotherapy.

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“We are very pleased that the FDA has granted trastuzumab emtansine a Priority Review, as we know people with HER2-positive metastatic breast cancer still need new treatment options," said Hal Barron, MD, chief medical officer and head of Global Product Development with Genentech, a member of the Roche Group.

The FDA will make its final ruling on February 26, 2013.

On October 1st, the company announced results of the Phase III EMILIA study, which showed that people with previously treated HER2-positive metastatic breast cancer lived longer after being treated with T-DM1 compared to those who received a combination of lapatinib and Xeloda (capecitabine).

Trastuzumab emtansine is what’s called an antibody-drug conjugate (ADC). It’s made up of the antibody trastuzumab and the chemotherapy DM1.

It’s thought to work by scrambling the signals that promote cancer growth and also calls on the body’s immune system to attack the cancer.

Genentech licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.

Building on the results of trastuzumab emtansine studies to date, there are approximately 25 ADCs in Genentech and Roche's pipeline.

Reviewed by: 
Review Date: 
November 5, 2012
Last Updated:
December 30, 2013