FDA grants priority review to Roche's BC drug

FDA Grants Breast Cancer Treatment BLA Priority Review.

Reuters (11/7, Ail) reports that the Roche Group's Genentech unit announced Tuesday that the Food and Drug Administration has granted priority review to its Biologics License Application for an investigational breast cancer treatment, trastuzumab emtansine (T-DM1). The South San Francisco-based the pharmaceutical company said the FDA is expected to make an approval decision on trastuzumab emtansine by Feb. 26. According to the announcement, Genentech partnered with ImmunoGen to develop the antibody-drug conjugate for the treatment of advanced breast cancer in patients previously treated with a standard therapeutic combination of Herceptin (trastuzumab) and a taxane chemotherapy.

http://www.reuters.com/article/2012/11/06/us-roche-breastcancerdrug-idUSBRE8A51JL20121106