FDA approves Kadcyla (Genentech/Roche) for HER2-positive metastatic Breast Cancer patients
The FDA has approved Kadcyla (trastuzumab emtansine), from Genentech/Roche, for the treatment of people with HER2-positive metastatic Breast Cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The approval is based on results from EMILIA, a Phase III randomized study comparing Kadcyla to lapatinib in combination with Xeloda (capecitabine) in 991 people with HER2-positive Breast Cancer. The study met both co-primary efficacy endpoints of overall survival and progression-free survival: people who received Kadcyla lived a median of 5.8 months longer than those who received the combination (median overall survival: 30.9 months vs. 25.1 months).
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