FDA approves pembrolizumab for advanced SCLC


The Food and Drug Administration has granted accelerated approval to pembrolizumab 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.

A stamp saying "FDA approved." Olivier Le Moal/Getty Images

Approval was based on an overall response rate of 19% among 83 patients with SCLC who had disease progression on or after two or more prior lines of therapy enrolled in two nonrandomized trials, according to the FDA.

SCLC cohorts in KEYNOTE-028 and KEYNOTE-158 received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until documented disease progression, unacceptable toxicity, or for a maximum of 24 months.

The ORR was 19% (95% confidence interval, 11%-29%), while the complete response rate was 2%. Responses were durable for 6 months or longer in 94% of the 16 responding patients.

Common adverse reactions included fatigue, decreased appetite, cough, nausea, and constipation. The most frequent serious adverse reactions were pneumonia and pleural effusion.

The recommended dosage for SCLC treatment is 200 mg, administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression, the FDA said.

Pembrolizumab is marketed as Keytruda by Merck.

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