On October 2, 2025, the US Food and Drug Administration (FDA) announced the approval of the combination treatment of lurbinectedin (Zepzelca®) plus atezolizumab (Tecentriq®) as the first maintenance (ongoing) therapy for patients with extensive-stage small cell lung cancer (ES-SCLC).
This approval is for patients who are currently benefiting from initial treatments, such as atezolizumab or atezolizumab plus chemotherapy.
Atezolizumab is an immunotherapy that blocks the PD-L1 protein on cancer cells. This allows the immune system to target and kill the cancer. Atezolizumab can be administered intravenously or by injection.
Lurbinectedin is a type of chemotherapy that is known to damage DNA in cancer cells and ultimately causes cell death. It is given to patients intravenously.
This FDA approval is supported by data from the phase 3 IMforte clinical trial that was conducted internationally. The trial studied 483 patients who had completed initial treatment for ES-SCLC and their disease continued to be well controlled. Patients were randomly assigned to the control group (receiving ongoing atezolizumab) or the test group (receiving ongoing lurbinectedin plus atezolizumab).
Data from the study showed patients in the control group lived for an average of 10.6 months compared to 13.2 months in the test group. Researchers also found that the combination treatment delayed cancer growth by approximately 46%.
For more information, including information on side effects, please see the FDA’s press release and speak with your medical team.