Jazz Pharmaceuticals has received the US Food and Drug Administration (FDA) Priority Review for the combination of Zepzelca (lurbinectedin) and Tecentriq (atezolizumab).
The combination is indicated for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC).
The US regulator accepted the biopharmaceutical company’s supplemental New Drug Application (sNDA) for the Zepzelca-Tecentriq combination.
Its decision is based on data from the Phase 3 IMforte trial, which showed significant improvements in both progression-free and overall survival for patients.
The sNDA application targets patients whose ES-SCLC has not progressed after initial treatment with atezolizumab, carboplatin, and etoposide.
The Prescription Drug User Fee Act (PDUFA) action date is set for 7 October 2025.
Jazz Pharmaceuticals executive vice president, research and development global head and chief medical officer Rob Iannone said: “The FDA’s Priority Review designation for Zepzelca in combination with atezolizumab as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer, a disease with limited therapeutic options and high unmet need.
“We are pleased to have received this review designation after presenting the IMforte trial data at ASCO 2025 with simultaneous publication in The Lancet.
“Together, these milestones bring us a step closer to potentially offering patients a new first-line maintenance option that could help extend the time they live without their disease progressing.”
Zepzelca is an alkylating drug that binds to DNA, disrupting the cell cycle and potentially leading to cell death.
It received accelerated approval from the FDA in June 2020 for treating metastatic small-cell lung cancer in adults, based on the overall response rate and response in a clinical study.
The Phase 3 IMforte trial showed the Zepzelca combination met its primary endpoints.
Patients receiving had a median progression-free survival of 5.4 months compared to 2.1 months for those on atezolizumab alone.
Median overall survival was 13.2 months versus 10.6 months, respectively.
The combination reduced the risk of disease progression or death by 46% and the risk of death by 27%.
Jazz Pharmaceuticals, in collaboration with PharmaMar, initiated the LAGOON confirmatory Phase 3 trial in December 2021.
The clinical trial aims to confirm the benefits of Zepzelca for patients with relapsed small-cell lung cancer and could support full approval in the US if successful.
Earlier this year, Jazz Pharmaceuticals signed a definitive agreement to acquire biopharmaceutical company Chimerix for about $935m.
