Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots:

• The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025)
• The sNDA was based on P-III (IMforte) trial results, showing Zepzelca + atezolizumab, met both 1EPs and improved PFS and OS vs atezolizumab alone
• The trial showed improved PFS (1EP) by 46% & a decrease in death risk by 27%, with mOS of 13.2 vs 10.6mos. & mPFS of 5.4 vs 2.1mos.

Ref: Prnewswire | Image: Prnewswire| Press Release

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