On 14 September 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product dabrafenib (Finlee), intended for the treatment of low- and high-grade glioma (LGG and HGG).
The applicant for this medicinal product is Novartis Europharm Limited.
Finlee will be available as a 10 mg dispersible tablet. The active substance of Finlee is dabrafenib, a protein kinase inhibitor (ATC code: L01EC02) which inhibits RAF kinases. Oncogenic BRAF mutations lead to constitutive activation of the RAS/RAF/MEK/ERK pathway, and are implicated in cell cycle progression, cell proliferation and arresting apoptosis. The most commonly observed BRAF mutation is V600E, which has been identified in 19% of paediatric LGG and approximately 5% of paediatric HGG.
The benefits of Finlee in combination with trametinib are an increased overall response rate (ORR; 46.6% versus 10.8%) and progression-free survival (20.1 versus 7.4 months) compared to carboplatin and vincristine chemotherapy for LGG, and an ORR of 56.1% and duration of response of 22.2 months measured in a single-arm study for HGG.
The most common side effects of dabrafenib in combination with trametinib were pyrexia, rash, headache, vomiting, fatigue, dry skin, diarrhoea, haemorrhage, nausea, dermatitis acneiform, neutropenia, abdominal pain, and cough.
The full indication is:
Low-grade glioma
Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with LGG with a BRAF V600E mutation who require systemic therapy.
High-grade glioma
- Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with HGG with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
- Finlee should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.
This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.
