CHMP positive for Finlee + trametinib for the treatment of low and high grade glioma – Novartis

On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product 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% vs 10.8%) and progression free survival (PFS; 20.1 vs 7.4 months) compared to carboplatin and vincristine chemotherapy for LGG, and an ORR of 56.1% and duration of response (DOR) of 22.2 months measured in a single-arm trial 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.