The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)
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: Day One | Image: Day One
Related News:- Day One Entered into an Exclusive License Agreement and Research Collaboration with Sprint Bioscience for VRK1 Program
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.