Failed Confirmatory Trial Won’t Force Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says

Jazz/PharmaMar’s SCLC drug will stay on the market while two more trials with different designs are conducted after confirmatory trial did not meet overall survival endpoint. Citizen petition requesting agency withdraw lurbinectedin underscores vagaries of accelerated approval.

Citizen petition asks FDA to withdraw approval of Zepzecla for treatment of small cell lung cancer
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The US Food and Drug Administration denied a citizen petition request that it withdraw accelerated approval of Jazz Pharmaceuticals plc/PharmaMar, S.A.’s Zepzelca (lurbinectedin) as a second-line treatment for small cell lung cancer (SCLC) because a confirmatory trial failed to meet its primary endpoint of overall survival. The agency cited aspects of the study, including use of a lower dose of Zepzelca, that could have led to its failure, and noted that the sponsor is conducting two additional confirmatory trials with a different design.

The agency’s response provides further perspective on its handling of accelerated approval when a confirmatory trial fails. The issue has gotten intense scrutiny with the public hearing on the Center...

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