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Roche ( RHHBY ) recently announced that the US Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of patients suffering from HER2-positive metastatic breast cancer (mBC).
These patients were previously treated with Herceptin (trastuzumab) and taxane chemotherapy.
The approval was based on positive results from a phase III study (EMILIA: N=991). The study compared Kadcyla (trastuzumab emtansine) to GlaxoSmithKline's ( GSK - Analyst Report ) Tykerb (lapatinib) along with Roche’s Xeloda (capecitabine) in these patients.
Roche has partnered with ImmunoGen, Inc. ( IMGN - Snapshot Report ) for Kadcyla. We note that Roche filed a New Drug Application (NDA) for Kadcyla in Jan 2013 after being granted a priority review in the US in Nov 2012.
In Aug 2012, Roche had filed a Biologics License Application (BLA) for Kadcyla for the treatment of HER2-positive unresectable locally advanced or metastatic breast cancer patients.
Roche also submitted a marketing authorization application for Kadcyla to the European Medicines Agency (EMA) for use in treatment-experienced HER2-positive metastatic breast cancer patients. The application is currently under review.
Meanwhile, in Dec 2012, the European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for Perjeta (pertuzumab) plus Herceptin (trastuzumab) and docetaxel to treat patients with HER2-positive metastatic or locally recurrent unresectable breast cancer (mBC).
The approval of Kadcyla will strengthen Roche's HER2 franchise. Roche expects Perjeta, Kadcyla and Actemra to positively impact results in 2013.
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