EMD SERONO INC — Tepmetko FDA Review (NDA/BLA 214096, 2025)
Merck KGaA · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
Tepmetko (tepotinib) received traditional FDA approval on February 15, 2024, for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations, fulfilling a postmarketing requirement. The recommended dosage is 450 mg orally once daily. This approval is based on updated data from the single-arm VISION study (NCT02864992), which evaluated 313 patients (164 treatment-naïve, 149 previously treated). The study demonstrated an overall response rate (ORR) of 51.4% and a median duration of response (DOR) of 18.0 months, with consistent efficacy across subgroups, including those with brain metastasis (ORR 64.1%). Median progression-free survival was 11.2 months and overall survival was 19.6 months. Common adverse events included peripheral edema, hypoalbuminemia, and increased creatinine. The FDA generally agreed with the safety assessment, noting potential for fetal harm and providing contraception advice.
Key findings — cited to the page
| Nausea (Grades 3 to 4) | 1.3 % | TEPMETKO (tepotinib) · p.15 |
| Dyspnea (All Grades) | 24 % | TEPMETKO (tepotinib) · p.15 |
| Edema (Grades 3 to 4) | 16 % | TEPMETKO (tepotinib) · p.15 |
| Nausea (All Grades) | 31 % | TEPMETKO (tepotinib) · p.15 |
| Musculoskeletal pain (All Grades) | 30 % | TEPMETKO (tepotinib) · p.15 |
| Musculoskeletal pain (Grades 3 to 4) | 3.2 % | TEPMETKO (tepotinib) · p.15 |
| Diarrhea (Grades 3 to 4) | 0.6 % | TEPMETKO (tepotinib) · p.15 |
| Edema (All Grades) | 81 % | TEPMETKO (tepotinib) · p.15 |
| Fatigue (All Grades) | 30 % | TEPMETKO (tepotinib) · p.15 |
| Fatigue (Grades 3 to 4) | 1.9 % | TEPMETKO (tepotinib) · p.15 |
| Diarrhea (All Grades) | 29 % | TEPMETKO (tepotinib) · p.15 |
| Dyspnea (Grades 3 to 4) | 2.6 % | TEPMETKO (tepotinib) · p.15 |
Source: Merck KGaA ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →