Jazz Pharmaceuticals plc’s (JAZZ) Zepzelca, in combination with Roche’s Tecentriq, is under priority review by the FDA, with a decision due on October 7, 2025.The combination is proposed as a first-line maintenance treatment for people with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with Tecentriq, carboplatin, and etoposide. In a phase III trial, Zepzelca plus Tecentriq demonstrated statistically significant and clinically meaningful improvements in both progression-free and overall survival in the extensive-stage small cell lung cancer first-line maintenance setting.Zepzelca received the FDA’s accelerated approval in June 2020 for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The drug generated annual net product sales of $320.3 million in 2024 and $137.5 million in the first half of 2025.JAZZ closed Friday’s (September 26, 2025) trading at $127.00, down 0.63%.