Roche/Genentech Win FDA Approval for Antibody-Drug Conjugate

Published on: February 22, 2013

FDA approved Roche?s antibody-drug conjugate, Kadcyla (trastuzumab emtansine or T-DM1), for the treatment of people with HER2-positive metastatic breast cancer.

FDA approved Roche’s Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is an antibody-drug conjugate (ADC) composed of the monoclonal antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. The linker and toxin were developed through a licensing agreement with ImmunoGen, a Massachusetts-based biotech company specializing in targeted anticancer therapies.

According to an FDA press release, patients treated with Kadcyla had a median progression-free survival of 9.6 months compared with 6.4 months in patients treated with another chemotherapy drug, lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.

Kadcyla is the first ADC to result from Roche and Genentech’s 30 years of HER2 pathway research and the third medicine Roche has developed for the treatment of HER2-positive breast cancer, according to Roche’s press release. In addition, Roche and Genentech currently have more than 25 antibody-drug conjugates in their pipeline.