CHMP recommends Kadcyla for Breast Cancer
Roche has announced that the European Union�s (EU) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Kadcyla (trastuzumab emtansine or T-DM1) as a single agent, for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic Breast Cancer who previously received trastuzumab and a taxane, separately or in combination.
The CHMP opinion is based on clinical data from the international, Phase III EMILIA study which found that Kadcyla helped people with HER2-positive locally advanced or metastatic Breast Cancer who had previously been treated with Herceptin and a taxane chemotherapy to live for nearly 10 months (9.6 months) without their disease getting worse and extended their life expectancy to more than two and a half years overall (30.9 months). Kadcyla has also demonstrated a tolerable safety profile and is associated with fewer of the severe side effects usually experienced with current chemotherapy known to impact patients� daily lives.
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