Posted by Michael Wonder on 15 Jun 2020
Jazz Pharmaceuticals announces U.S. FDA accelerated approval of Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer
15 June 2020 - Zepzelca is approved under accelerated approval based on overall response rate and duration of response demonstrated in an open-label, monotherapy clinical trial.
Jazz Pharmaceuticals today announced along with its partner PharmaMar that the U.S. FDA approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Zepzelca was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
