Tepmetko FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2024.
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.
- Tepmetko is indicated for use in adult patients with metastatic non-small cell lung cancer whose tumors have an abnormal mesenchymal epithelial transition (MET) gene as detected by an FDA approved test.
- Tepmetko was granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) in the VISION trial (NCT02864992). The conversion to traditional approval was granted on February 15, 2024 based on an additional 161 patients and an added 28 months of follow-up time to assess DOR.
- 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
Further information
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