In the phase 3 MAVERICK trial, people with small cell lung cancer who had regular brain MRIs instead of preventive whole-brain radiation kept their memory and thinking intact longer, with no clear survival difference so far.
News|Articles|October 9, 2026
FDA Withdraws Zepzelca Approval for Previously Treated Small Cell Lung Cancer
Author(s)Quincy Attobrah
The FDA withdrew Zepzelca’s accelerated approval for small cell lung cancer after the LAGOON trial failed to show longer survival. Its maintenance use with Tecentriq is unaffected.
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On Sept. 30, 2026, the FDA withdrew the accelerated approval of Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer (SCLC) whose cancer grew during or after platinum-based chemotherapy. The date appears on the FDA's list of withdrawn cancer accelerated approvals.
The withdrawal does not affect Zepzelca's other approved use. In October 2025, the FDA
Why the Approval Was Withdrawn
Accelerated approval lets the FDA approve a drug for a serious disease based on early signs that it works, such as how often tumors shrink, before studies show that it helps people live longer or better. The drug's maker must then run a larger study, called a confirmatory trial, to check that benefit.
Zepzelca received accelerated approval for previously treated SCLC in June 2020, based on how often tumors shrank and how long those responses lasted. Its confirmatory study was the phase 3 LAGOON trial, which did not meet its main goal. In its second-quarter financial results, released Aug. 3, 2026, Jazz Pharmaceuticals said that, based on LAGOON and in alignment with the FDA, it planned to ask the agency to remove the second-line indication from the label.
What the Trial Tested
LAGOON enrolled 724 people at more than 200 sites in the United States, Canada and Europe. All had SCLC that had grown after platinum-containing chemotherapy, with or without immunotherapy. They were randomly assigned to one of three groups:
- Zepzelca alone at the approved U.S. dose (240 people)
- A lower dose of Zepzelca plus irinotecan, a chemotherapy drug (242 people)
- The doctor's choice of chemotherapy, either topotecan or irinotecan (242 people)
The main goal was overall survival, meaning how long people lived after joining the trial.
What It Found
Neither Zepzelca group lived longer than the chemotherapy group. Median overall survival, the point at which half the people in a group were still alive, was:
- 8.7 months with Zepzelca alone
- 10.9 months with Zepzelca plus irinotecan
- 10.7 months with topotecan or irinotecan
Among people whose cancer had spread to the brain or spinal cord, a smaller group, median survival was 7.1 months with Zepzelca alone (58 people) compared with 10.3 months with chemotherapy (56 people).
Side Effects
Jazz reported no new safety concerns. Serious (grade 3 or higher) treatment-related side effects occurred in 35% of people who received Zepzelca alone, 62.6% of those who received Zepzelca plus irinotecan and 64.4% of those who received chemotherapy.
What's Still Unknown
Full LAGOON results have not yet been published in a peer-reviewed journal; the numbers in this article come from Jazz’s June 12, 2026, announcement. Public statements also do not specify what people currently receiving Zepzelca for previously treated SCLC should do, so treatment decisions should be made with their oncologist. Additionally, LAGOON did not test Zepzelca as maintenance treatment with Tecentriq; that approval was based on the separate phase 3 IMforte trial.
What It Means for You
If you are receiving Zepzelca after platinum chemotherapy, do not stop treatment on your own. Talk with your oncologist about whether it is still the right choice for you and what other approved treatments or clinical trials are available.
If you are receiving Zepzelca with Tecentriq as maintenance treatment for extensive-stage SCLC, this withdrawal does not change that approval.
Questions to Ask Your Care Team
- Am I receiving Zepzelca for the use that was withdrawn, or as maintenance treatment?
- Is my cancer responding to my current treatment, and should we change anything?
- What other approved treatments or clinical trials are options for me?
- Will my insurance continue to cover my treatment after this change?
References
- "Withdrawn | Cancer Accelerated Approvals." U.S. Food and Drug Administration. Accessed Oct. 8, 2026.
- "Jazz Pharmaceuticals Provides Update on Zepzelca (lurbinectedin) Phase 3 LAGOON Trial in Second-Line Small Cell Lung Cancer." Jazz Pharmaceuticals. June 12, 2026.
- "Jazz Pharmaceuticals Announces Second Quarter 2026 Financial Results." Jazz Pharmaceuticals. Aug. 3, 2026.
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