23 April 2024: Day One’s Ojemda gets accelerated approval for pediatric brain tumour with BRAF gene fusions.

The Food & Drug Administration (FDA) gave?accelerated?approval to Day?One’s?Ojemda (Tovorafenib) for treating pediatric patients with?pediatric relapsed/refractory pediatric low-grade glioma (pLGG) with BRAF fusions & BRAF V600 mutations.

Day?One’s?first commercial product will also be the first?FDA approved?therapy for pLGG with BRAF fusions.

Day One gained?the?accelerated approval along with a priority review voucher based on?it’s?FIREFLY-1 trial data?where Ojemda showed?overall response rate of 51%, including a 52% response rate in the BRAF fusion group that is currently not treated by the Tafinlar and Mekinist combination from Novartis.

The company is currently conducting the Phase 3 FIREFLY-2 trial for Ojemda as the?first-line?monotherapy in patients aged 6 months - 25?years.

Based on a JP Morgan analysis,?the?once weekly?therapy is expected to?get?$750 million due to the larger patient population and lack of warning labels on the box.?Day One?is?also?exploring?Ojemda with?it’s?MEK inhibitor candidate, pimasertib, for adult patients.

Source: FiercePharma