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# Jazz to Remove Zepzelca Second-Line Indication
- URL: https://www.fdaweb.com/jazz-to-remove-zepzelca-second-line-indication/
- Published: 2026-08-04T12:00:00.000Z
- Updated: 2026-09-14T13:44:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161570

Jazz Pharma says it will seek FDA approval to remove Zepzelca’s (lurbinectedin) second-line metastatic small cell lung cancer (SCLC) indication based on data from the company’s LAGOON trial. In June, Jazz reported ([see earlier story](https://www.fdaweb.com/jazz-trial-misses-survival-endpoint-for-zepzelca-in-lung-cancer/)) that the confirmatory study failed to meet its primary endpoint of overall survival, raising questions about the future of the drug's second-line indication. The results came almost a year after FDA granted full approval to Zepzelca in the first-line maintenance setting based on the Phase 3 IMforte trial. Jazz emphasized that the LAGOON findings do not affect the drug's approved first-line maintenance indication.

Zepzelca received accelerated FDA approval in 2020 for adults with metastatic SCLC whose disease progressed on or after platinum-based chemotherapy, based on tumor response and duration of response data.