FDA withdraws Zepzelca's accelerated approval in second-line small cell lung cancer

What's the deal? The US Food and Drug Administration (FDA) withdrew the accelerated approval of Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer (SCLC) whose disease progressed during or after platinum-based chemotherapy, effective 30 September 2026. The removal follows the Phase 3 LAGOON confirmatory trial, which failed to show an overall survival benefit over standard chemotherapy in this second-line setting. The withdrawal does not affect Zepzelca's separate 2025 approval as a maintenance treatment, in combination with Genentech's Tecentriq, for extensive-stage SCLC.

Why it matters: Small cell lung cancer is an aggressive form of lung cancer with limited treatment options after chemotherapy fails. Zepzelca, made by Jazz Pharmaceuticals, won accelerated approval in June 2020 based on how often tumours shrank in a single-arm study; under FDA rules that status depends on confirming real clinical benefit in a follow-up trial. LAGOON enrolled 724 relapsed patients and did not confirm the survival benefit, so the second-line indication has been removed — a reminder that accelerated approvals are conditional and can be withdrawn when confirmatory data fall short.

Read more: Cure Today, 9 October 2026