Binimetinib (2) – Mektovi®
Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with encorafenib
Characteristics
| Start date | 01.10.2024 – Marketing authorisation: 29.08.2024 |
|---|---|
| Resolution | 20.03.2025 |
| INN | Binimetinib |
| Brand name | Mektovi® |
| Pharm. company | Pierre Fabre Pharma GmbH |
| G-BA Procedure ID | D-1113 |
| ATC code | L01EE03 MEK inhibitors (L01EE) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
Studies and Results
- Clinical trials
- The PHAROS Phase II trial – which is currently ongoing, open-label, multicentre and single-arm – enrolled patients with metastatic NSCLC harbouring a BRAF V600 mutation – 59 patients in the first-line setting and 39 previously treated patients.
a) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and a BRAF V600E mutation; first-line treatment
- An additional benefit is not proven.
- As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.
b) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% and a BRAF V600E mutation; first-line treatment
- The additional benefit is not proven.
- As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.
c) Adults with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation; following first-line treatment
- An additional benefit is not proven.
- As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.
Courtesy translation only, please refer to the German original.
Associated procedures
| Binimetinib (2) | Mektovi® | Pierre Fabre Pharma GmbH | Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with encorafenib | 122–476 | 100% additional benefit not proven | |
| Binimetinib (1) | Mektovi® | Pierre Fabre Pharma GmbH | Melanoma, BRAF V600 mutation, combination with encorafenib | 1,390 | 100% additional benefit not proven |
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