FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves First Immuno-Oncology Drug for Certain Patients Previously Treated for Lung Cancer

Aug. 21, 2018
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Bristol-Meyers Squibb’s Opdivo received the first ever approval from the FDA for treating patients with metastatic small lung cancer whose cancer has progressed after receiving platinum-based chemo and at least one other line of therapy.

The approval was granted under accelerated approval and was based on overall response rate and duration of response.

The agency said continuing approval for Opdivo may rely on verifying and describing its clinical benefit in future clinical trials.

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