Jazz Pharmaceuticals announced FDA has approved Zepzelca in combination with Atezolizumab (Tecentriq) as a maintenance treatment for adults suffering from extensive-stage small cell lung cancer (ES-SCLC), and whose disease has not progressed after first-line induction therapy with Atezolizumab, carboplatin and etoposide.¹ The National Comprehensive Cancer Network (NCCN) updated the NCCN Clinical Practice Guidelines in Oncology for SCLC to now include Zepzelca and Atezolizumab’s combination as a preferred regimen for patients who are diagnosed with ES-SCLC and whose disease hasn’t progressed following four cycles of platinum-based chemotherapy and Atezolizumab induction.¹

"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."

What is FDA’s approval based off?

FDA’s approval of Zepzelca and Atezolizumab’s combination is based on results from the Phase III IMforte trial, which displayed the combination’s ability to reduce the risk of disease progression or death by 46% and the risk of death by 27%, compared to Atezolizumab therapy alone.¹ From the point of randomization, the median overall survival for the Zepzelca and Atezolizumab combination was 13.2 months, compared to 10.6 months for Atezolizumab alone, following four cycles of induction therapy.¹ Additional findings from the Phase III trial showed from the point of randomization media progression-free survival through isolated assessment was 5.4 months, compared to 2.1 months. The Phase III trial also revealed the most common adverse reactions to the combination including the following:

• Decreased lymphocyte
• Fatigue
• Decreased platelets
• Asthenia
• Decreased hemoglobin,
• Nausea
• Decreased leukocytes,
• Decreased neutrophils

"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."

Sources

1. FDA Approves Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer Jazz Pharmaceuticals October 2, 2025 https://investor.jazzpharma.com/news-releases/news-release-details/fda-approves-zepzelcar-lurbinectedin-and-atezolizumab-tecentriqr