Merck B V — Tepmetko EMA EPAR public assessment report (EMEA/H/C/005524, 2022)
Merck B V · 2022 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Tepmetko (tepotinib) for advanced NSCLC with METex14 skipping alterations. It details the drug's chemistry, manufacturing, and non-clinical profile, including its selective MET inhibition and potential environmental risks. Clinical sections cover extensive pharmacokinetic studies, efficacy and safety data from the VISION Phase II trial, and the impact of renal/hepatic impairment. While acknowledging tolerability issues and limitations of single-arm data, the CHMP granted marketing authorization, deeming the benefit-risk balance positive for second-line use, despite some dissenting opinions regarding the need for randomized confirmatory trials.
Key findings — cited to the page
| Dose modification for other adverse reactions (Grade 3 or higher) | Reduce Tepmetko to 225 mg until the adverse reaction recovers to ≤ grade 2. A temporary interruption of Tepmetko treatment for no more than 21 days can also be considered. | Tepmetko · p.14 |
| Pneumonia (Grade ≥ 3) | 3.8 % | VISION Cohorts A+C · p.148 |
| Oedema (any grade) | 77.3 % of patients | VISION Cohorts A+C · p.148 |
| Hypoalbuminaemia (any grade) | 28.5 % | VISION Cohorts A+C · p.148 |
| Peripheral oedema (Grade ≥ 3) | 11 % | VISION Cohorts A+C · p.148 |
| Hypoalbuminaemia (Grade ≥ 3) | 5.8 % | VISION Cohorts A+C · p.148 |
| Diarrhoea (any grade) | 27.8 % | VISION Cohorts A+C · p.148 |
| Pleural effusion (Grade ≥ 3) | 4.1 % | VISION Cohorts A+C · p.148 |
| Peripheral oedema (any grade) | 65.6 % | VISION Cohorts A+C · p.148 |
| Nausea (any grade) | 30.2 % | VISION Cohorts A+C · p.148 |
| Increase in creatinine (any grade) | 27.1 % | VISION Cohorts A+C · p.148 |
| Lipase increased (Grade ≥ 3) | 3.8 % | VISION Cohorts A+C · p.148 |
Source: Merck B V ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →