Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
News|Articles|February 22, 2013
Roche/Genentech Win FDA Approval for Antibody-Drug Conjugate
Author(s)Amy Ritter, PhD
FDA approved Roche?s antibody-drug conjugate, Kadcyla (trastuzumab emtansine or T-DM1), for the treatment of people with HER2-positive metastatic breast cancer.
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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
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
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