Posted by Michael Wonder on 13 Nov 2020
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer
13 November 2020 - Today, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10) as determined by an FDA approved test.
FDA also approved the PD-L1 IHC 22C3 pharmDx (Dako) as a companion diagnostic for selecting patients with triple negative breast cancer for pembrolizumab.
