Posted by Michael Wonder on 23 Sep 2017
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent locally advanced or metastatic gastric or gastro-oesophageal junction cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
22 September 2017 - First anti-PD-1 therapy approved in the U.S. for these patients with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under the FDA’s accelerated approval regulations based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
