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Tepmetko FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

FDA Approved: Yes (First approved February 3, 2021)
Brand name: Tepmetko
Generic name: tepotinib
Dosage form: Tablets
Company: EMD Serono, Inc.
Treatment for: Non-Small Cell Lung Cancer

Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

  • This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Tepmetko is indicated for use in adult patients whose tumors have an abnormal mesenchymal epithelial transition (MET) gene as detected by an FDA approved test.
  • Tepmetko is taken once daily with food until disease progression or unacceptable toxicity.
  • Patients taking Tepmetko should be warned of the increased risk of severe or fatal interstitial lung disease/pneumonitis, hepatotoxicity, and the potential risk of embryo-fetal toxicity requiring the use of effective contraception during and shortly after treatment.
  • Common adverse reactions include edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.

Development timeline for Tepmetko

Feb  3, 2021Approval FDA Approves Tepmetko (tepotinib) as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations
Aug 25, 2020FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations

Further information

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