June 18, 2019
Impact Level: High
- FDA has granted accelerated approval to Keytruda (pembrolizumab) monotherapy for 3L treatment of metastatic SCLC. According to Keytruda’s revised label, it is indicated for use after platinum-based chemotherapy and one other line of therapy.
- This approval is based on pooled data from the KEYNOTE-158 (Phase 2) and KEYNOTE-028 (Phase 1b) trials.