Lurbinectedin Approved as Part of Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
The FDA has approved the DNA-damaging agent in combination with immunotherapy for patients whose cancers have not progressed after first-line therapy.
The U.S. Food and Drug Administration (FDA) has approved lurbinectedin (Zepzelca) in combination with atezolizumab—administered either intravenously (IV) (Tecentriq) or subcutaneously (Tecentriq Hybreza)—for the maintenance treatment of adults with extensive-stage small cell lung cancer (SCLC) that has not progressed after first-line induction therapy consisting of atezolizumab and chemotherapy.
Lurbinectedin, a synthetic DNA-targeting agent derived from compounds produced by symbiotic bacteria that live within Caribbean sea squirts, inhibits transcription and causes DNA breaks and eventual cell death. Previously, lurbinectedin was granted accelerated approval for patients with metastatic SCLC that had progressed after prior therapy. Atezolizumab is a type of immunotherapy known as an immune checkpoint inhibitor, and it targets the PD-L1 protein to prevent suppression of immune responses against cancer.
The approval is based on results from the multicenter, open-label, randomized phase III IMforte trial involving 483 patients with extensive-stage SCLC that did not progress after finishing induction therapy involving IV atezolizumab and chemotherapy. Patients were randomly assigned (1:1) to receive IV atezolizumab alone or in combination with lurbinectedin.
Patients who received the combination had a significantly lower risk of death during the trial period. Half of those who received the combination survived at least 13.2 months compared with 10.6 months of those treated with atezolizumab only, equivalent to a 27% reduction in the risk of death during the follow-up period.
Patients treated with the lurbinectedin and IV atezolizumab combination also experienced significantly longer time until disease progression, with half experiencing at least 5.4 months before progression compared with 2.1 months in patients who received IV atezolizumab alone, which corresponded to a 46% reduction in the risk of progression.
The recommended IV infusion dose for lurbinectedin is 3.2 mg/m2 of body surface area every three weeks. The recommended dose for IV atezolizumab is 840 mg every two weeks, 1,200 mg every three weeks, or 1,680 mg every four weeks. The recommended dose for the subcutaneous immunotherapy formulation is 1,875 mg of atezolizumab and 30,000 units of hyaluronidase every three weeks. All the above treatments and doses are recommended to be given until disease progression or unacceptable toxicity.
SCLC is a fast-growing form of lung cancer, and extensive-stage describes small cell lung cancers that have spread to other parts of the body. According to federal statistics, it was estimated that 226,650 individuals would be diagnosed with lung cancer and 124,730 would die of the disease in the United States in 2025.
The FDA rendered its decision on October 2, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.