FDA

FDA OK’s lurbinectedin combo for extensive-stage SCLC

October 9, 2025

FDA has approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease hasn’t progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

Efficacy

Efficacy was evaluated in IMforte (NCT05091567), a randomized, multicenter, open-label trial in patients receiving first-line treatment for ES-SCLC. In the study, 483 patients with ES-SCLC whose disease hadn’t progressed after completion of four cycles of atezolizumab, carboplatin, and etoposide (induction treatment) were randomized (1:1) to receive either lurbinectedin in combination with atezolizumab IV or atezolizumab IV alone until disease progression or unacceptable toxicity.

Major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) assessed by independent review facility (IRF) according to RECIST v.1.1, measured from the time of randomization after completion of induction therapy. Median OS was 13.2 months (95% CI, 11.9-16.4) in the lurbinectedin with atezolizumab arm and 10.6 months (95% CI, 9.5-12.2) in the atezolizumab arm (hazard ratio [HR], 0.73; 95% CI, 0.57-0.95]; two-sided p-value, 0.0174). Median PFS was 5.4 months (95% CI, 4.2-5.8) and 2.1 months (95% CI, 1.6-2.7) in the respective arms (HR, 0.54; 95% CI, 0.43-0.67]; two-sided p-value, <0.0001).

Safety

The prescribing information for lurbinectedin includes warnings and precautions for myelosuppression, hepatotoxicity, extravasation resulting in tissue necrosis, rhabdomyolysis, and embryo-fetal toxicity. The prescribing information for atezolizumab and for atezolizumab and hyaluronidase-tqjs include warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Recommended dose

The recommended lurbinectedin dose is 3.2 mg/m² by IV infusion every 21 days until disease progression or unacceptable toxicity. The recommended atezolizumab dose is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks by IV infusion until disease progression or unacceptable toxicity. The recommended dosage of atezolizumab and hyaluronidase-tqjs is 1875 mg of atezolizumab and 30,000 units of hyaluronidase administered SC every 3 weeks until disease progression or unacceptable toxicity.

Sources:

FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive

Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination granted U.S. FDA priority review for first-line maintenance treatment of extensive-stage small cell lung cancer. [News release]. 2025. https://investor.jazzpharma.com/news-releases/news-release-details/fda-approves-zepzelcar-lurbinectedin-and-atezolizumab-tecentriqr