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FDA approves T-DM1

February 23, 2013 1:22 AM UTC

FDA approved a BLA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Kadcyla ado-trastuzumab emtansine ( T-DM1) to treat HER2-positive metastatic breast cancer in patients who have received prior treatment with Herceptin trastuzumab and a taxane-based chemotherapy regimen. Kadcyla's label includes a boxed warning on the risk of hepatotoxicity, cardiac and embryo-fetal toxicity. Genentech said it plans to launch the product within two weeks at a monthly cost of $9,800, which the company said translates to about $94,000 for a 9.6-month average course of therapy. Genentech said Kadcyla will also be available through patient assistance programs. ...