Lurbinectedin (Zepzelca)

Key facts

• Zepzelca has more than one FDA-labeled small-cell lung cancer use; the treatment setting and combination matter.
• The 2020 accelerated approval covers disease progression on or after platinum-based chemotherapy.
• The 2025 indication covers specified maintenance treatment with atezolizumab after first-line induction without progression.
• The full FDA label should be checked for current dosing, blood-count monitoring, liver tests, interactions, and adverse reactions.

Second-line metastatic small-cell lung cancer use

In June 2020, the FDA granted accelerated approval for adults with metastatic small-cell lung cancer with disease progression on or after platinum-based chemotherapy.

The supporting single-arm study reported tumor response outcomes; accelerated approval can require confirmatory evidence.

Maintenance combination use

In October 2025, the FDA approved lurbinectedin with atezolizumab, or atezolizumab and hyaluronidase, for maintenance treatment in adults with extensive-stage small-cell lung cancer whose disease had not progressed after the specified first-line induction regimen.

The maintenance indication is different from treatment after progression, so source dates and the exact clinical setting should be checked.

Primary sources

• FDA: 2020 accelerated approval of lurbinectedin — FDA approval notification for metastatic small-cell lung cancer after progression on platinum therapy.
• FDA: oncology approval notifications — FDA listing that includes the October 2025 lurbinectedin maintenance-combination approval.
• FDA: Zepzelca orphan-drug approvals and labeled indications — FDA database entry listing both approved labeled indications.