Horizon scanning: US FDA approves ado-trastuzumab emtansine or T-DM1 (KadcylaT) for HER2-positive metastatic breast cancer

Source: BioSpace Area: News The US FDA has approved the antibody-drug conjugate ado-trastuzumab emtansine or T-DM1 (KadcylaT) for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with trastuzumab (Herceptin®) and a taxane.   KadcylaT, which is composed of the cytotoxic agent DM1 conjugated to trastuzumab, is the first antibody-drug conjugate to be approved by the FDA for the treatment of metastatic breast cancer. The approval was based on the results of the EMILIA Phase III study (n=991), which compared KadcylaT alone to lapatinib in combination with capecitabine in women with HER2-positive locally advanced or metastatic breast cancer who had previously been treated with trastuzumab and a taxane chemotherapy agent.  KadcylaT was found to improve progression-free survival (median 9.6 months vs. 6.4 months in patients treated with lapatinib plus capecitabine; HR 0.65; p<0.0001) and overall survival (30.9 months vs. 25.1 months; HR 0.68; ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news