Safety and effectiveness of tepotinib in patients with unresectable, advanced or recurrent non-small cell lung cancer with METex14 skipping alterations: post-marketing surveillance in Japan.

ABSTRACT:

Objective

Tepotinib has shown clinical benefits in patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping alterations. The objective of this post-marketing surveillance (PMS) was to assess the safety and effectiveness of tepotinib in general clinical practice in Japan.

Methods

This multicenter, non-interventional PMS included patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations who received at least one dose of tepotinib. The primary endpoint was the incidence of adverse drug reactions (ADRs) identified as safety specifications (SS) for tepotinib according to the Japanese Risk Management Plan (ADRs of SS); i.e. interstitial lung disease (ILD), fluid retention, hepatic function disorder, renal impairment

SUBMITTER: Kato T 

PROVIDER: S-EPMC12501971 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature