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# FDA Approves Combo for Lung Cancer Maintenance
- URL: https://www.fdaweb.com/fda-approves-combo-for-lung-cancer-maintenance/
- Published: 2025-10-02T12:00:00.000Z
- Updated: 2026-09-14T15:23:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159979

FDA has approved Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) in combination with atezolizumab (Genentech’s Tecentriq) or atezolizumab and hyaluronidase-tqjs (Genentech’s Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The approval covers patients whose disease has not progressed following initial treatment with atezolizumab or atezolizumab and hyaluronidase-tqjs, along with carboplatin and etoposidem, according to an FDA [news release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive?utm%5Fmedium=email&utm%5Fsource=govdelivery). 

Approval was based on data from the Phase 3 IMforte trial (NCT05091567), which enrolled 483 patients with ES-SCLC. After completing four cycles of first-line induction therapy, participants were randomized to receive either lurbinectedin plus atezolizumab or atezolizumab alone, FDA says. The combination demonstrated a statistically significant improvement in both overall survival and progression-free survival, it adds. Patients receiving lurbinectedin with atezolizumab had a median overall survival of 13.2 months, compared with 10.6 months for those on atezolizumab alone.

FDA notes that lurbinectedin’s prescribing information includes risks of myelosuppression, hepatotoxicity, tissue damage from extravasation, rhabdomyolysis, and embryo-fetal toxicity. Atezolizumab and Tecentriq Hybreza carry warnings for severe immune-mediated reactions, infusion-related events, complications following stem cell transplant, and embryo-fetal toxicity.