FDA Approves Genentech's Antibody-Drug Conjugate, Marking Third Rx for HER2-Targeted Breast Cancer | GenomeWeb

The US Food and Drug Administration last week approved Roche/Genentech's latest HER2-targeting breast cancer drug, trastuzumab emtansine (T-DM1).

The drug was granted priority review by the FDA last year with a decision due by Feb. 26. The agency approved the drug, brand named Kadcyla, a few days early on Feb. 22. Kadcyla is indicated as a treatment for patients with HER2-positive, late stage, metastatic breast cancer, who were previously treated with the HER2-targeting drug Herceptin and taxane chemotherapy.

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