FDA denies request for accelerated approval of T-DM1

August 27, 2010

Pharmaceutical company Roche submitted a request for accelerated approval of T-DM1 for women with advanced HER2-positive breast cancer who had received prior treatment, including other HER2-targeted treatments, in July, 2010.  The FDA has denied the request.  Roche will continue with EMILIA, a Phase III trial of T-DM1, and expects to submit an application for regular approval in mid-2012.  Read the press release from the company here.

T-DM1 is a combination of trastuzumab and chemotherapy - an antibody-drug conjugate.  The hypothesis is that by adding trastuzumab to the chemotherapy, the chemotherapy can be delivered directly to the cancer cells, through binding with the HER2-positive cancer cells.

The FDA is currently considering whether to revoke accelerated approval of another Roche product, Avastin, for the treatment of HER2-negative, metastatic breast cancer.