Finlee

Finlee is a drug for which an application was submitted on 9 September 2022, and it received an orphan medicinal product designation on 09 December 2020. A CHMP positive opinion was issued on 14 September 2023.

In efficacy studies, Finlee demonstrated an Overall Response Rate (ORR) of 46.6% by independent review, compared to an ORR of 10.8% for the comparator arm, with an odds ratio for ORR of 7.19 and a p-value of <0.001. The median duration of exposure to dabrafenib and trametinib was 72.7 weeks. For comparison, the ORR for carboplatin and vincristine in unselected paediatric LGG ranged from 29% to 35%, and for chemotherapy in paediatric LGG patients with BRAF V600 mutation, it was 10%. Response rates for temozolomide monotherapy or combinations in recurrent/refractory paediatric HGG were 0-12%, and for targeted agents in paediatric HGG, they were less than 10%.

Regarding safety, 98.8% of patients treated with Finlee experienced at least one adverse event. In the comparator arm (C+V), vomiting was reported in 48.5% of patients. The median duration of exposure to dabrafenib was 75.7 weeks and to trametinib was 75.7 weeks. In combination therapy, 114 patients were treated with D+T, and 171 patients were in the combination therapy pool. 56.1% of patients received D+T for ≥56 weeks.