Zepzelca Approved for Metastatic Small Cell Lung Cancer

The FDA has granted accelerated approval to Pharma Mar’s and Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) for treatment of adults with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.

The accelerated approval was based on positive results from a trial of 105 patients. Continued approval for the indication may be contingent upon confirmatory trials to verify its clinical benefit.

Jazz Pharma plans to make Zepzelca commercially available as early as next month.