The U.S. Food and Drug Administration (FDA) has granted approval to Jazz Pharmaceuticals' Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as the first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following initial induction therapy with atezolizumab, carboplatin, and etoposide. ' Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as the first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following initial induction therapy with atezolizumab, carboplatin, and etoposide.

This landmark approval introduces the first-ever combination therapy in this setting for ES-SCLC, an aggressive cancer with a high risk of relapse after initial positive response, and is intended to provide a proactive approach to delay disease progression and extend survival.

The National Comprehensive Cancer Network (NCCN) has already updated its clinical guidelines to include this Zepzelca and atezolizumab combination as a preferred maintenance regimen.

This FDA decision is based on the results from the pivotal Phase 3 IMforte trial, which demonstrated a significant clinical benefit for the combination regimen. Compared to atezolizumab maintenance therapy alone, the Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%. Specifically, the median overall survival (OS) for patients receiving the combination was 13.2 months versus 10.6 months for the control group, and the median progression-free survival (PFS) was 5.4 months versus 2.1 months. While providing a critical new option for this challenging disease, the therapy is associated with potential side effects, with the most common adverse reactions, including laboratory abnormalities, being decreased lymphocytes, decreased platelets, decreased hemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue or asthenia. As SCLC is the most aggressive form of lung cancer and typically returns quickly after initial treatment, this new maintenance approach is considered a meaningful advancement in the standard of care.