© 2025 MJH Life Sciences™ and CURE - Oncology & Cancer News for Patients & Caregivers. All rights reserved.
Spencer, Assistant Editor of CURE®, has been with MJH Life Sciences since 2024. A graduate of Rowan University with a bachelor's degree in health communication, Spencer enjoys spending time with family and friends, hiking, playing guitar and rock climbing.
FDA granted priority review to Zepzelca plus Tecentriq for first-line maintenance in extensive-stage small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has accepted the supplemental new drug application of Zepzelca (lurbinectedin) plus Tecentriq (atezolizumab) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with Tecentriq, Paraplatin (carboplatin) and Vepesid (etoposide) , according to a news release from Jazz Pharmaceuticals plc.
The application was granted priority review, with a target action date of October 7, 2025. Priority review is given to drug applications that may meaningfully improve the treatment, prevention or the diagnosis of serious conditions, as per the release.
"The FDA's Priority Review designation for Zepzelca in combination with Tecentriq as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer, a disease with limited therapeutic options and high unmet need," Dr. Rob Lannone said in the news release. "We are pleased to have received this review designation after presenting the IMforte trial data at ASCO 2025 with simultaneous publication in The Lancet. Together, these milestones bring us a step closer to potentially offering patients a new first-line maintenance option that could help extend the time they live without their disease progressing."
Progression-free survival (PFS): Time a patient lives without cancer worsening.
Overall survival (OS): Time from treatment start until death from any cause.
Myelosuppression: Low blood cell counts causing increased risk of infection, bleeding or fatigue.
Sepsis: Severe, potentially life-threatening infection.
Central line: A catheter inserted into a large vein to deliver medications safely and reduce vein damage.
Lannone is the executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals
The supplemental new drug application for Zepzelca in combination with Tecentriq was based on results from the phase 3 IMforte trial, which met both primary end points by showing statistically significant improvements in key survival end points compared with Tecentriq alone.
After receiving four cycles of induction therapy with Paraplatin, Vepesid and Tecentriq, patients whose disease had not progressed were randomly assigned to receive either Zepzelca plus Tecentriq or Tecentriq alone. From the point of randomization, the median progression-free survival was 5.4 months with the combination versus 2.1 months with Tecentriq alone. Median overall survival was 13.2 months versus 10.6 months, respectively. The combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared with Tecentriq alone. No new or unexpected safety signals were observed.
Zepzelca works by attaching to DNA at guanine sites, setting off a chain of events that interferes with proteins involved in DNA repair and transcription, according to the release. This can disrupt the cancer cell’s life cycle and may lead to cell death.
The FDA granted accelerated approval to Zepzelca in June 2020 for those whose metastatic small cell lung cancer has progressed after treatment with platinum-based chemotherapy. The decision was based on overall response rate and how long responses lasted in a clinical trial.
A phase 3 trial called LAGOON began in 2021 to confirm Zepzelca’s benefit for patients with relapsed disease. If the trial is successful, it could support full FDA approval.
Zepzelca for injection (4 milligrams) is currently available under accelerated approval, with continued approval depending on results from confirmatory studies, as per the release.
Zepzelca can cause low blood counts, raising the risk of infection, bleeding, or fatigue. Severe infections like sepsis are rare. Blood counts should be checked before each dose, with treatment delayed or adjusted if needed. Liver problems may occur and require monitoring with blood tests before and during treatment. The drug can leak from the vein during infusion, potentially causing serious skin damage; using a central line may reduce this risk.
In addition, muscle breakdown has been reported, so monitoring with blood tests is recommended. Zepzelca can harm unborn babies, so birth control is advised during treatment and afterward, and breastfeeding should be avoided during treatment and for two weeks after the last dose. Common side effects include low blood counts, fatigue, nausea, muscle pain and changes in liver or kidney tests.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.
Related Content:
