Shots:
The US FDA has granted accelerated approval to Ojemda for treating r/r pLGG patients (≥6mos.) with BRAF fusion/rearrangement or BRAF V600 mutation. It further obtained FDA’s rare pediatric disease priority review voucher
The approval was based on the P-II (FIREFLY-1) study assessing the efficacy (arm 1, n=77) & safety (arm 2, n=60) of Ojemda.…
