TEPMETKO(tepotinib)

TEPMETKO (tepotinib) is an established name for a New Molecular Entity (NME) with Priority Status, submitted for regulatory review on May 28, 2020, June 15, 2020, and June 29, 2020 (Final), with a PDUFA Goal Date of February 28, 2021. The review was completed on February 1, 2021.

In overall ITT, tepotinib demonstrated a median Progression-Free Survival (PFS) of 8.6 months and a median Overall Survival (OS) of 19.1 months. The Objective Response Rate (ORR) by Investigator assessment was 54.8%, with a median Duration of Response (DOR) of 14.0 months. For prior platinum-treated patients, the median PFS was 11.0 months, and the median OS was 19.8 months. The ORR in prior platinum-treated patients was 50.0%, with a median DOR of 12.4 months. In platinum-naïve patients, the median PFS was 8.5 months, and the median DOR was 10.8 months.

Safety findings include a 0.6% incidence of Diarrhea (Grades 3 to 4). Dose modifications are specified for elevated ALT and/or AST levels, including permanent discontinuation for ALT and/or AST > 3 times ULN with total bilirubin > 2 times ULN, or for ALT and/or AST > 20 times ULN. For other Grade 3 or higher adverse reactions, a dose reduction to 225 mg or temporary interruption for no more than 21 days may be considered. A total of 922 participants were treated with tepotinib in the clinical development program.