On October 2, 2025, the Food and Drug Administration approved lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

Full prescribing information for lurbinectedin, atezolizumab, and atezolizumab and hyaluronidase-tqjs will be posted on Drugs@FDA. 

Efficacy and Safety

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

The 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 randomisation 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).

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 Dosage

The recommended lurbinectedin dose is 3.2 mg/m2 by intravenous 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 intravenous 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 subcutaneously every 3 weeks until disease progression or unacceptable toxicity.

Expedited Programs

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Australia’s Therapeutic Goods Administration, Health Canada, Israel’s Ministry of Health, and Switzerland’s Swissmedic. The application reviews are ongoing at these agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. Lurbinectedin and atezolizumab received orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Source: FDA