Lurbinectedin can now be prescribed for adults with metastatic small cell lung cancer that progressed on or after platinum-based chemotherapy.

The agency based the approval of lurbinectedin (Zepzelca; Jazz Pharmaceuticals, PharmaMar) — an alkylating drug that binds guanine residues within DNA — on data from the multicenter, open-label, multicohort PM1183-B-005-14 trial, which included 105 patients with metastatic small cell lung cancer who experienced disease progression on or after receiving platinum-based chemotherapy.

Patients received 3.2 mg/m2 IV lurbinectedin every 21 days until disease progression or unacceptable toxicity.

Investigator-assessed overall response rate and duration of response served as the study’s main efficacy outcomes.

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