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Tepotinib Approved in Japan for MET-Positive NSCLC

Jason M. Broderick @jasoncology
Published: Wednesday, Mar 25, 2020

lung cancer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved tepotinib (Tepmetko) for the treatment of patients with unresectable, advanced or recurrent non–small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations.1 

Regarding safety, the majority of TRAEs were of grade 1/2, and no grade 4/5 TRAEs were observed. All-grade TRAEs reported by ≥10% of 87 patients who were evaluable for safety included peripheral edema (48.3%), nausea (23.0%), diarrhea (20.7%), and increased blood creatinine (12.6%). Additional relevant TRAEs, the company stated, included increased lipase (4.6%), fatigue (3.4%), and vomiting (3.4%). Four patients had to permanently discontinue treatment due to TRAEs; these included peripheral edema (n = 2), interstitial lung disease (n = 1), and diarrhea and nausea (n = 1).

References           

  1. TEPMETKO® (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations. Published online March 25, 2019. https://prn.to/2UDtB4v. Accessed March 25, 2019.
  2. ArcherDX Receives Approval for Archer®MET Companion Diagnostic for TEPMETKO® (Tepotinib) in Advanced Non-Small Cell Lung Cancer in Japan. Published online March 25, 2019 https://prn.to/3ajadR9. Accessed March 25, 2019.
  3. Pain PK, Veillon R, Cortot AB, et al. Phase II study of tepotinib in NSCLC patients with METex14 mutations. J Clin Oncol. 2019;37 (suppl; abstr 9005). doi: 10.1200/JCO.2019.37.15_suppl.9005

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