Shots:
- The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy
- Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG pts (6mos. to 25yrs.) across 2 arms: Arm 1 (n=77) for efficacy analyses & Arm 2 for safety data for an additional 60 pts
- Trial showed an improved ORR of 71% per RANO-HGG & 53% per RAPNO-LGG criteria, with clinical benefit rate of 77% & 58%, respectively. Based on RAPNO-LGG, among responders, the median time to response was 5.4mos. & mDoR was 18mos.
Ref: Ipsen | Image: Ipsen | Press Release
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