Core Insights - The FDA has accepted the supplemental New Drug Application (sNDA) for Zepzelca in combination with atezolizumab for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC), with a PDUFA action date set for October 7, 2025 [1][2] - The sNDA submission is based on the Phase 3 IMforte trial results, which showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for the combination therapy compared to atezolizumab alone [2][6] - Jazz Pharmaceuticals will host an investor webcast to discuss the Zepzelca data, featuring commentary from experts in the field [3] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, including a growing portfolio of cancer treatments [25][26] - The company is headquartered in Dublin, Ireland, and is dedicated to transforming the lives of patients with limited therapeutic options [25][26] Industry Context - Small cell lung cancer (SCLC) accounts for approximately 13% of lung cancers in the U.S., with around 30,000 new cases reported annually [4] - SCLC is known for its aggressive nature and rapid spread, leading to a high unmet need for effective treatment options [4]