Roche's Tecentriq Combo Wins Key FDA Nod for Lung Cancer
First-of-its-kind maintenance therapy approved for extensive-stage small cell lung cancer, a historically difficult-to-treat malignancy.
Genentech, a member of the Roche Group, has secured a significant victory in the oncology space after its combination therapy . The decision greenlights the use of Tecentriq (atezolizumab) in combination with Zepzelca (lurbinectedin) for the first-line maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
This approval marks a pivotal development, establishing the first and only FDA-approved combination therapy specifically for the maintenance setting of this aggressive cancer. ES-SCLC is notoriously fast-growing with a high rate of relapse after initial treatment, and physicians have had limited options to prevent or delay recurrence. This new regimen is indicated for patients who have not experienced disease progression after initial platinum-based chemotherapy with Tecentriq.
The FDA's decision was underpinned by compelling data from the Phase III IMforte study. The trial results showed the combination therapy delivered clinically meaningful improvements in survival, having or death compared to Tecentriq alone. The median overall survival was 13.2 months for the combination versus 10.6 months for the monotherapy arm.
For Roche and its partner on Zepzelca, Jazz Pharmaceuticals, the approval opens up and has the potential to establish a new standard of care. With approximately 30,000 new cases of SCLC diagnosed in the U.S. annually, this new maintenance option addresses a critical unmet need and could significantly alter the treatment landscape for thousands of patients.