10 June 2025 - Target action (PDUFA) date set for 7 October 2025.
Jazz Pharmaceuticals today announced the US FDA has accepted the supplemental new drug application for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) 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 atezolizumab, carboplatin, and etoposide for priority review.