The FDA has approved lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer with disease progression, following platinum-based chemotherapy, according to PharmaMar and Jazz Pharmaceuticals plc.
"It is great to see a new therapeutic agent available for patients with relapsed SCLC," said Charles M. Rudin, chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and principal investigator of the National Cancer Institute Small Cell Lung Cancer Consortium in a press release. "Lurbinectedin is the first new drug approved for second line treatment since 1996. SCLC remains a major unmet medical need. Many of us in the oncology community will welcome lurbinectedin as a new standard option for patients with recurrent SCLC."
The regulatory decision is based on monotherapy clinical data reported from an open-label multicenter, single-arm study of 105 patients with platinum-sensitive and -resistant or relapsed SCLC. Results from the trial showed that treatment with lurbinectedin resulted in an overall response rate (ORR) of 35% and a median duration of response (DOR) of 5.3 months per investigator assessment. By independent review committee, the ORR with the agent was 30% and the DOR was 5.1 months.
The approval will permit Jazz Pharmaceuticals to make lurbinectedin commercially available in the United States in early July 2020.
A version of this article originally spread on OncLive® as "FDA Approves Lurbinectedin for Metastatic Small Cell Lung Cancer".