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Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional approval of Ipsen’s Ojemda (tovorafenib) as monotherapy for pediatric low‑grade glioma with BRAF fusions, rearrangements or V600 mutations. The recommendation is based on the Phase II FIREFLY‑1 trial, which evaluated 137 relapsed or refractory patients aged six months to 25 years and reported an overall response rate of 71% per RANO‑HGG criteria and 53% per RAPNO‑LGG criteria. Clinical benefit was observed in 77% of patients, with a median time to response of 5.4 months and a median duration of response of 18 months. Ojemda thus targets a critical unmet need for children who have progressed after at least one systemic therapy.