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Jazz Pharmaceuticals said it plans to ask the FDA to remove the second-line indication for lurbinectedin (Zepzelca) in metastatic small-cell lung cancer (SCLC).
In its second-quarter 2026 financial results, the company said it expects to submit a labeling supplement in the third quarter of 2026 for the FDA’s review and subsequent action on the second-line indication.
Lurbinectedin received accelerated approval from the FDA in 2020 in the second-line setting for adults with metastatic SCLC whose disease had progressed on or after platinum-based chemotherapy.
The approval was based on a 35% investigator-assessed response rate and a median response duration of 5.3 months in the 105-patient study. The FDA-approval notice stated that “continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”
Jazz’s plan to remove the second-line indication follows negative results from the phase 3 LAGOON trial, a postmarketing study that evaluated lurbinectedin alone or with irinotecan vs the investigator’s choice of topotecan or irinotecan in 724 patients whose metastatic SCLC had progressed after platinum-containing chemotherapy.
The study did not meet its primary endpoint of overall survival. Median overall survival was 8.7 months in the lurbinectedin monotherapy group vs 10.7 months in the control (hazard ratio [HR], 1.19; 95% CI, 0.959-1.476) and 10.9 months with lurbinectedin plus irinotecan vs 10.7 months with control therapy (HR, 0.902; 95% CI, 0.729-1.115).
The planned label change will not affect lurbinectedin’s separate first-line maintenance indication in SCLC.
