FDA Approves Jazz’s Zepzelca + Tecentriq Combo For Small Cell Lung Cancer Maintenance

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced that the U.S. FDA has approved Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC). This approval applies to patients whose disease has not progressed after initial induction therapy with atezolizumab, carboplatin, and etoposide. It represents the first FDA-approved combination therapy for first-line maintenance treatment of ES-SCLC, a particularly aggressive cancer with limited treatment options.

"For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse," said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital. "The Zepzelca and Tecentriq 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 chemotherapy with Tecentriq and chemotherapy. The approval may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival."

The NCCN Guidelines® for SCLC have also been updated to include Zepzelca in combination with atezolizumab as a preferred regimen for patients who remain stable after platinum-based chemotherapy and atezolizumab induction. This update underscores the growing recognition of the regimen as a new standard of care for maintenance therapy in ES-SCLC.

"ES-SCLC patients have good initial responses but then quickly progress. Extending the time to progression, and ultimately survival, will be clinically valuable, in particular in this fast-moving cancer," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "The introduction of a new maintenance approach offers a new way to manage this aggressive disease and gives patients and their physicians a new treatment option with the potential to increase both PFS and OS. We're proud to advance the standard of care for ES-SCLC and we continue to pursue opportunities in cancer research that improve lives."

Approval was supported by data from the Phase 3 IMforte trial, which demonstrated that the Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and reduced the risk of death by 27% compared to atezolizumab alone. The regimen showed a median overall survival of 13.2 months versus 10.6 months, and a median progression-free survival of 5.4 months versus 2.1 months. The most common adverse reactions included reduced blood counts, nausea, and fatigue. Results were presented at ASCO 2025 and published in The Lancet.