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FDA Approves Nivolumab for Small Cell Lung Cancer

Jason M. Broderick @jasoncology
Published: Friday, Aug 17, 2018

The FDA has granted an accelerated approval to single-agent nivolumab (Opdivo) for the treatment of patients with small cell lung cancer (SCLC) with disease progression following platinum-based chemotherapy and 1 other line of therapy.

The ORR in the single-agent nivolumab arm was 10% (95% CI, 5-18), and the ORRs were 23% (95% CI, 13-36) and 19% (95% CI, 9-31) in the N1/I3 and N3/I1 arms, respectively. Responses generally consisted of partial responses, with 1 complete response seen in the N1/I3 arm. Stable disease rates were 22%, 21%, and 17%, in the single-agent, N1/I3, and N3/I1 arms, respectively. Across arms, both platinum-sensitive and -resistant patients responded to treatment.


The median DOR was not yet reached with single-agent nivolumab. In the N3/I1 group, the median DOR was 4.4 months (95% CI, 3.7-not reached). In the N1/I3 group, the median DOR was 7.7 months (95% CI, 4.0-not reached).

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