Jazz Pharma : FDA Approves Zepzelca + Tecentriq Combo For First-Line Maintenance In ES-SCLC Patients

Jazz Pharmaceuticals

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(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) announced that it has received U.S. FDA approval for Zepzelca (lurbinectedin) in combination with either atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance therapy for adults with extensive-stage small cell lung cancer (ES-SCLC). This approval applies to patients whose disease has not progressed following initial treatment with atezolizumab, carboplatin, and etoposide.

The milestone marks the first FDA-approved combination regimen for first-line maintenance in ES-SCLC—a highly aggressive and fast-growing cancer with historically limited therapeutic options.

The National Comprehensive Cancer Network (NCCN) updated the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for SCLC to include the Zepzelca and atezolizumab combination as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.

The FDA approval is based on results from the Phase 3 IMforte trial, which showed that the Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone.

The most common adverse reactions for Zepzelca in combination with atezolizumab including laboratory abnormalities, (= 30%) are decreased lymphocytes, decreased platelets, decreased hemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.

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