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SCLC, Small Cell Lung Cancer

Lurbinectedin Combination gets FDA Approval for Extensive-Stage SCLC

Posted on October 6, 2025
Post Views: 2

SCLC, Small Cell Lung CancerThe U.S. Food and Drug Administration (FDA) has approved lurbinectedin (Zepzelca) in combination with atezolizumab or and hyaluronidase-tqjs for adults with extensive-stage small cell lung cancer (ES-SCLC) without disease progression after frontline induction therapy with atezolizumab, carboplatin and etoposide. The approval was based on the results of randomized, multicenter, open-label IMforte clinical trial. The results from IMforte were presented at the 2025 American Society of Clinical Oncology Annual Meeting.

About the IMforte Clinical Trial

This phase 3 study included 483 patients with ES-SCLC who were previously receiving first-line treatment. Also, they did not have disease progression after four cycles of atezolizumab, carboplatin, and induction etoposide. The patients were then assigned to receive either lurbinectedin in combination with atezolizumab or atezolizumab alone.

Key Findings from the Study

The study showed that they Tecentriq and lurbinectedin combination reduced the risk of disease progression by 46% and death risk by 27% in comparison with Tecentriq maintenance therapy alone. The major efficacy outcome measures were overall survival and progression-free survival.

Expert Insights

Roy Herbst, an investigator on the trial said, “The Tecentriq and Zepzelca combination provides a new option and a proactive approach in this setting shown to improve progression-free and overall survival in patients who haven’t progressed after standard induction treatment with Tecentriq and chemotherapy.”

Recommended Dosage and Safety Information

The recommended dosage of lurbinectedin is 3.2 mg/m² by intravenous infusion every 21 days until disease progression. The recommended dosage for atezolizumab 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 prescribing information for lurbinectedin includes warning and precautions for myelosuppression, hepatotoxicity and extravasation resulting in tissue necrosis.

Conclusion

This new maintenance approach paves a new way to manage small cell lung cancer. It has the potential to increase both PFS and OS. With continued research and FDA-backed advancements like this, treatment options for SCLC patients are steadily improving and offering renewed hope.

The information shared in this blog is for educational purposes only. You should always consult with your healthcare provider for any medical needs.

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