Novartis AG — Tabrecta EMA EPAR public assessment report (EMEA/H/C/004845, 2022)
Novartis AG · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for Novartis' Tabrecta (capmatinib) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. The report details the drug's chemical, pharmaceutical, and biological aspects, including manufacturing, quality control, and non-clinical safety studies. Clinical pharmacology, efficacy, and safety were assessed primarily through Study A2201, which demonstrated high and durable objective response rates in both treatment-naïve and pretreated patients, including intracranial activity. Common adverse events included peripheral edema and nausea, with specific safety concerns like hepatotoxicity and ILD/pneumonitis also noted. The report also contextualizes Tabrecta's efficacy against the natural history of MET-dysregulated NSCLC, acknowledging the limitations of single-arm studies.
Key findings — cited to the page
| Grade 3-4 Oedema peripheral (all A2201 patients) | 9.9 % | · p.150 |
| subjects experiencing Grade ≥ 3 AEs | 70.2 % | Study A2201 · p.157 |
| Grade 3 or 4 adverse reaction rate (fatigue) | 8.1 % | · p.148 |
| Grade 3-4 Oedema peripheral (MET amplified patients) | 7.0 % | · p.150 |
| Grade 3-4 Blood creatinine increased (MET amplified patients) | 0 % | · p.150 |
| Grade 3-4 Blood creatinine increased (all A2201 patients) | 0.3 % | · p.150 |
| overall incidence of Grade ≥3 adverse events | 70.2 % | · p.159 |
| Grade 3 or 4 adverse reaction rate (peripheral oedema) | 14.4 % | · p.148 |
| Grade 3 or 4 adverse reaction rate (dyspnoea) | 6.9 % | · p.148 |
| Grade 3-4 Oedema peripheral (MET mutant patients) | 13.8 % | · p.150 |
| Grade 3-4 Blood creatinine increased (MET mutant patients) | 0.6 % | · p.150 |
| most common Grade ≥ 3 AEs: oedema peripheral | 9.9 % | · p.157 |
Source: Novartis AG ↗ · 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 →