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. Also enrolling patients for P-III (FIREFLY-2/LOGGIC) studies of tovorafenib as front-line therapy in pLGG patients (6mos. to 25yrs.) in US, Canada, EU, Australia & Asia
- The results, in arm 1 (n=76 evaluable; data cutoff: Jun 5, 2023), showed 51% ORR, incl. 28% PRs & 11% MRs; 52% & 50% ORR in patients with BRAF fusions or rearrangements (n=64) & with BRAF V600 mutation (n=12), respectively; 49% & 55% ORR in patients with prior MAPK-targeted therapy (n=45) and without it (n=31), respectively; 13.8mos. mDoR, whereas mToR was 5.3mos. and ORR is 53% by RANO LGG criteria. 66% of patients remain on study
Ref: GlobeNewswire | Image: Day One| Press Release
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