Roche Wins FDA Approval For New Lung Cancer Combination Therapy
The approval covers a first-line maintenance treatment for an aggressive form of small cell lung cancer, a historically difficult-to-treat disease.
Roche's Genentech unit has secured a significant regulatory win, receiving U.S. Food and Drug Administration approval for a new combination therapy to treat an aggressive form of lung cancer. The approval covers the use of its blockbuster immunotherapy drug, Tecentriq (atezolizumab), in combination with lurbinectedin (Zepzelca) for the first-line maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
This decision marks a critical advancement in a therapeutic area with historically limited options. available for the first-line maintenance of ES-SCLC, offering a new standard of care for patients who have not progressed after initial platinum-based chemotherapy.
The approval was supported by compelling data from the Phase 3 IMforte study. The trial demonstrated that the Tecentriq and lurbinectedin combination significantly improved patient outcomes compared to Tecentriq alone. Specifically, the regimen reduced the risk of disease progression or death by 46% and lowered the risk of death by 27%.
Patients receiving the combination therapy had a median overall survival of 13.2 months, compared to 10.6 months for those on Tecentriq monotherapy. , showing a median of 5.4 months for the combination versus just 2.1 months for the control arm. In response to these findings, the National Comprehensive Cancer Network (NCCN) has already updated its clinical practice guidelines to include the regimen as a preferred option.
For Roche, the approval reinforces the standing of Tecentriq as a cornerstone of its oncology franchise and expands its application in the competitive lung cancer market. Small cell lung cancer accounts for about 15% of all lung cancer diagnoses and is particularly aggressive, making new treatment options a high priority for clinicians and a significant commercial opportunity for drugmakers. is expected to be a key growth driver for Roche's pharmaceutical division as it continues to build out its portfolio of cancer therapies.