FDA approves tepotinib for metastatic non-small cell lung cancer
Regulatory approval: On Feb 15, 2024, the FDA granted traditional approval to tepotinib (Tepmetko) for adults with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. Tepotinib previously received accelerated approval (Feb 3, 2021) based on ORR and DOR from the VISION trial; conversion was supported by additional patients and longer follow-up assessing DOR. ORR and DOR were reviewed by a blinded independent review committee.
FDA regulatory update (traditional approval)
On February 15, 2024, the FDA granted traditional approval to tepotinib (Tepmetko; EMD Serono, Inc.) for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations.
Tepotinib previously received accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) data from VISION (NCT02864992), a multicenter, non-randomized, open-label, multicohort study. The FDA stated the conversion to traditional approval was based on an additional 161 patients and 28 more months of follow-up to assess DOR.
Efficacy (Blinded Independent Review Committee)
Efficacy was demonstrated in 313 patients with metastatic NSCLC harboring MET exon skipping alterations who received tepotinib 450 mg once daily until progression or unacceptable toxicity.
- Treatment-naïve (n=164): ORR 57% (95% CI, 49–65); 40% of responders had DOR ≥12 months.
- Previously treated (n=149): ORR 45% (95% CI, 37–53); 36% of responders had DOR ≥12 months.
Safety and dosing
Most common adverse reactions (≥20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The recommended dose is 450 mg orally once daily with food.
The application received breakthrough therapy and orphan drug designations.