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WASHINGTON -- The FDA granted for the transcription inhibitor lurbinectedin (Zepzelca) as second-line therapy for metastatic small-cell lung cancer.

The approval pertains to patients whose disease progressed during or after initial platinum-based chemotherapy.

Support for conditional approval came from a phase II multicenter open-label trial involving 105 patients. The primary endpoint was investigator-assessed objective response rate (ORR), which proved to be 35%. Median response duration in that analysis was 5.3 months.

When examined by independent reviewers, the ORR was 30%, and median duration of response was 5.1 months.

Lurbinectedin, an analogue of the approved anticancer medical trabectedin (Yondelis), blocks oncogene transcription, leading to cell cycle arrest and ultimately to apoptosis.

The most common adverse events (≥20 of patients) associated with lurbinectedin treatment were myelosuppression, fatigue, increased creatinine, increased liver enzymes (alanine transaminase and aspartate transaminase), hyperglycemia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, hyponatremia, vomiting, cough, hypomagnesemia, and diarrhea.

According to the FDA statement, continued approval may be contingent on corroborating data from confirmatory trials. The accelerated approval was granted to Jazz Pharmaceuticals. According to a , lurbinectedin will be commercially available in early July.

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