Posted by Michael Wonder on 18 Jun 2019
FDA approves Merck’s Keytruda (pembrolizumab) as monotherapy for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
18 June 2019 - Marks first approval for Keytruda in small cell lung cancer.
Merck, today announced that the U.S. FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
This accelerated approval is 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. This marks the first indication for Keytruda in SCLC.
The approval was based on pooled data from KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1), two multicentre, multi-cohort, non-randomised, open-label trials evaluating Keytruda in patients with SCLC who had disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
