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 Oncological diseases 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 Oncological diseases Melanoma, BRAF V600 mutation, combination with encorafenib 1,390 100% additional benefit not proven


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