Jazz Pharma Scores FDA Win for New Lung Cancer Therapy
Zepzelca, in combination with Roche's Tecentriq, approved as first-line maintenance treatment for extensive-stage small cell lung cancer.
Jazz Pharmaceuticals (NASDAQ: JAZZ) and its partner Roche announced a significant regulatory victory on Wednesday after the U.S. Food and Drug Administration (FDA) approved a new combination therapy for a particularly aggressive form of lung cancer.
The agency gave its nod to the expanded use of Zepzelca (lurbinectedin) in combination with Roche's Tecentriq for the first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval provides a new and much-needed option for patients whose disease has not progressed after initial platinum-based chemotherapy.
The decision was based on compelling results from the Phase III IMforte study, which was co-funded by Jazz and Roche. The study demonstrated that the Zepzelca-Tecentriq combination compared to Tecentriq alone. Furthermore, the therapy showed a 46% reduction in the risk of disease progression or death, a significant statistical improvement.
"This approval marks a pivotal moment for patients with extensive-stage small cell lung cancer, a disease that has seen limited therapeutic innovation for decades," said a lead investigator in the study. The combination therapy is the first and only one of its kind approved for first-line maintenance in this setting.
According to the , the median overall survival for patients receiving the combination was 13.2 months, compared to 10.6 months for those on Tecentriq monotherapy. Small cell lung cancer accounts for about 10-15% of all lung cancer diagnoses and is characterized by rapid progression and poor prognosis.
This latest regulatory milestone builds on Zepzelca's previous accelerated approval in 2020 for second-line treatment of metastatic SCLC. The expanded label is expected to significantly bolster Jazz Pharmaceuticals' oncology portfolio and provide a new standard of care. The positive outcome underscores the success of the collaboration between Jazz and Roche in addressing critical unmet needs in cancer treatment. The new regimen has already been incorporated into the National Comprehensive Cancer Network (NCCN) guidelines as a preferred option, signaling strong support from the clinical community.