Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review.
Genentech (and Roche) is getting ready against biosimilar versions of trastuzumab, the blockbuster against breast and gastric cancers. Following the approvals of pertuzumab (Perjeta), the companies are now seeking approvals for T-DM1, which is a antibody-drug conjugate agianst breast cancer.
Trastuzumab emtansine’s proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer (mBC) who have received prior treatment with trastuzumab (Herceptin) and a taxane chemotherapy. The FDA confirmed the action date is February 26, 2013.
“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, M.D., chief medical officer and head, Global Product Development.
Roche’s Marketing Authorization Application for trastuzumab emtansine for people with HER2-positive mBC has also been accepted for review by the European Medicines Agency (EMA).
Trastuzumab emtansine is an antibody-drug conjugate (ADC) being studied in HER2-positive cancers. It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signaling and deliver the chemotherapy DM1 directly inside HER2-positive cancer cells.
Trastuzumab emtansine binds to HER2-positive cancer cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cancer cells. Once trastuzumab emtansine is taken up by those cancer cells, it is designed to destroy them by releasing the DM1.
Genentech licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.
Source: Genentech press release