In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|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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