Is lurbinectedin's use in ovarian cancer fda approved?

Is lurbinectedin FDA-approved for ovarian cancer?

Yes. Lurbinectedin (Zepzelca) has FDA approval for the treatment of adults with small cell lung cancer (SCLC), not ovarian cancer. The FDA approval for lurbinectedin is specific to SCLC (including relapsed/refractory disease), so its use in ovarian cancer is not FDA-approved based on that labeled indication. [1]

Where does ovarian cancer fit, then?

If you’re seeing lurbinectedin discussed for ovarian cancer, that typically reflects clinical research (trials) rather than an FDA-labeled indication. FDA approval requires evidence submitted to the agency for that specific cancer type and setting, which is not included in the ovarian cancer label. [1]

What does “off-label” mean here?

Using lurbinectedin for ovarian cancer outside its FDA-labeled indication would be considered off-label use. Off-label prescribing is possible in oncology, but it is not the same as being FDA-approved for ovarian cancer. [1]

What should patients or clinicians check next?

The most reliable check is the current FDA label/indications for lurbinectedin to confirm whether ovarian cancer appears anywhere in the labeled indications or any expanded approvals. [1]

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761299