In 2021, the FDA granted an accelerated approval to tepotinib for metastatic non-small cell lung cancer. Earlier on, tepotinib had been approved for the treatment of advanced non-small cell lung cancer by PMDA (Japan).
Check out this publication describing the population PK analysis conducted by Pharmetheus, in collaboration with colleagues at Merck, to support these regulatory approvals. The analysis demonstrated that none of the investigated covariates had an effect on tepotinib exposure requiring dose adjustments.
Find the publication here.
