The FDA approves Merck's (MRK +1.1%) Keytruda (pembrolizumab) for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and that express a protein called PD-L1 [such as Bristol-Myers Squibb's (BMY +3.2%) Opdivo (nivolumab)].
The data supporting the sBLA was generated from a subgroup of 61 NSCLC patients within a larger study who progressed following platinum-based chemo and targeted therapies for EGFR/ALK mutations, if present. The subgroup's tumors all expressed PD-L1 as determined by the 22C3 pharmDx companion diagnostic test. Participants received 10 mg/kg of Keytruda every two to three weeks. The results showed that treatment with Keytruda shrank tumors in 41% of patients with the effect lasting as long as 9.1 months.
The FDA designated Keytruda a Breakthrough Therapy for this indication.