The FDA has granted accelerated approval to tepotinib for adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
According to a release from the FDA, the approval was granted following positive results from the VISION trial. The trial included 152 patients who received a 450 mg oral dose daily until disease progression or unacceptable toxicity. The primary outcomes of the trial were overall response rate and response duration. The release noted that the overall response rate for treatment naïve patients was 43% (95% CI: 32%-56%) with a median response duration of 10.8 months (95% CI, 6.9-NA). For previously treated patients, the overall response rate was 43% (95% CI: 33-55%) with a median duration of 11.1 months (95% CI: 9.5-18.5).
The most common adverse reactions were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. The treatment can also cause interstitial lung disease, hepatoxicity, and embryo-fetal toxicity.
The release noted that the approval process was conducted under Project Orbis, involving other regulatory agencies, including Health Canada, the Australian Therapeutic Goods Administration, and Swissmedic.