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25-06-2019 | FDA | News

approvalsWatch

Pembrolizumab approved in USA for metastatic SCLC

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medwireNews: Following accelerated approval by the US FDA, pembrolizumab is now a third-line option for patients with metastatic small-cell lung cancer (SCLC).

Individuals who have progressed during or after platinum-based chemotherapy and have received at least one other line of therapy can be given the PD-1 inhibitor at a dose of 200 mg every 3 weeks. Treatment is to be continued until disease progression or unacceptable toxicity, or for up to 2 years in those without progression.

The decision is based on a pooled analysis of the KEYNOTE-028 and -158 trials that showed an overall response rate of 19%, with responses lasting for at least 6, 12, and 18 months in 94%, 63%, and 56% of patients, respectively.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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