New Article Discusses 35 Oncology Drugs Receiving Accelerated Approval

May 10, 2021

An article published in the New England Journal of Medicine (NEJM) discusses 35 oncology drugs that received accelerated approval from the Food and Drug Administration. Drugs receiving this designation do not always demonstrate purported benefits in randomized clinical trials. The authors also discuss how underpowered trials, patient selection, and statistical methods can affect the primary endpoint of a trial.

The authors note, “The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing that for 10 indications, the required trials did not end up confirming benefit and yet their marketing authorization continued,” adding, “The small percentage of drugs whose clinical benefit is ultimately not confirmed should be viewed not as a failure of accelerated approval but rather as an expected trade-off in expediting drug development that benefits patients with severe or life-threatening diseases.” Read more here.

(Source: Beaver & Pazdur, NEJM, 5/6/21)

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