Roche will file T-DM1 this year

April 2, 2012 8:42 AM

EMILIA study showed trastuzumab emtansine significantly extended the time people with HER2-positive metastatic breast cancer lived without their disease getting worse.

As discussed before in two different posts, Roche is trying to take necessary actions before the first trastuzumab biosimilar enters the market. Pertuzumab, a new monoclonal antibody which will be used in previously untreated HER2-positive metastatic breast cancer has already received the priority review from FDA.

Additionally, Roche is also working on self administration for Herceptin, which will probably protect Roche’s market share in breast cancer after the biosimilars, even biobetters of trastuzumab enter the market in the future.

Now, Roche declares that, trastuzumab emtansine (T-DM1), which is an investigational medicine known as an antibody-drug conjugate (ADC), gives positive results in progression-free survival (PFS). The medicine is comprised of the antibody trastuzumab and the chemotherapy agent DM1 attached together using a stable linker.  It is designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells.

“Trastuzumab emtansine represents a new approach for the treatment of patients with HER2-positive breast cancer that comes from our decades of research on the HER pathway,”  said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development.  “We are excited about the EMILIA results because trastuzumab emtansine is our first antibody drug conjugate and it may help people who still need more treatment options for this aggressive disease. We will work to submit these data to regulatory authorities as quickly as possible.”

Although final results for overall survival (OS), a co-primary efficacy endpoint of EMILIA, are not yet mature, based on these findings, Roche plans to submit a Marketing Authorisation Application to the European Medicines Agency (EMA) this year for trastuzumab emtansine in HER2-positive metastatic breast cancer.  In addition, Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the U.S. Food and Drug Administration (FDA) this year for the same indication.


Source: Roche press release

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