On June 17, 2019, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA) for 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. Though pembrolizumab is an established treatment option for non-small cell lung cancer, this is the first approval of pembrolizumab for small cell lung cancer.

This approval was based on two clinical trials, KEYNOTE-158 and KEYNOTE-028, which measured tumor response rate and durability of response.

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