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FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

The decision follows phase 3 data showing the regimen extends progression-free and overall survival compared with atezolizumab alone.

Dr Sabari on the FDA Approval of Maintenance Lurbinectedin Plus Atezolizumab for ES-SCLC | OncLive
Through this approval, Tecentriq-Zepzelca becomes the first and only maintenance therapy to secure FDA clearance to treat ES-SCLC. Image credit: Monster Ztudio via ShutterStock.com.
FDA Approval Insights: Maintenance Lurbinectedin Plus Atezolizumab for ES-SCLC: With Anne Chiang, MD, PhD; and Stephen Liu, MD

Overview

  • Eligibility covers adults whose disease has not progressed after induction with atezolizumab, carboplatin and etoposide, and the approval includes both intravenous Tecentriq and its subcutaneous Hybreza formulation.
  • IMforte showed median progression-free survival of 5.4 months vs 2.1 months (HR 0.54) and median overall survival of 13.2 months vs 10.6 months (HR 0.73) for the combination over atezolizumab alone.
  • The combination produced higher rates of adverse events, notably myelosuppression with anemia, thrombocytopenia and neutropenia, underscoring the need for close hematologic monitoring.
  • NCCN added the regimen as a preferred maintenance option for eligible non-progressors, marking the first approved dual maintenance therapy in this disease.
  • The approval expands Zepzelca’s role from its earlier accelerated, later-line use to a full maintenance indication, with experts advising selective use in fit patients with adequate counts.