Roche | MEDIA
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FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
The FDA has approved Tecentriq, including its subcutaneous formulation Tecentriq Hybreza, in combination with lurbinectedin for first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). This marks the first combination therapy for this specific treatment setting in ES-SCLC. The National Comprehensive Cancer Network® Guidelines now recommend this regimen as a preferred option. The IMforte phase III study demonstrated significant benefits, reducing the risk of disease progression or death by 46% and the risk of death by 27%. Median overall survival in the study was 13.2 months for the combination versus 10.6 months for Tecentriq alone. Progression-free survival also showed a substantial improvement with the combination therapy. This approval addresses a critical unmet need due to the high relapse rates in ES-SCLC. Roche and Jazz Pharmaceuticals partnered on this advancement, aiming to improve outcomes for challenging cancers. Tecentriq has an established role in ES-SCLC, previously approved in combination with chemotherapy for initial treatment. The combination is a proactive approach to delay disease progression and extend survival in patients whose cancer has not progressed after initial therapy.