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Onco-Summaries: Daily Oncology Updates at a Glance


22/04/2026











EC Grants Conditional Approval for Ojemda® in Relapsed/Refractory Pediatric Low‑Grade Glioma (Ref)


The European Commission granted conditional marketing authorization for Ojemda® (tovorafenib) as the first targeted therapy for relapsed/refractory pediatric low‑grade glioma (pLGG), regardless of BRAF alteration.


  • Scope: Applies to patients aged ≥6 months across all 27 EU Member States plus Iceland, Liechtenstein, and Norway


  • Clinical Basis: Approval supported by Phase II FIREFLY‑1 trial (137 patients), showing:


    • Overall response rate: 71% (RANO‑HGG) and 53% (RAPNO‑LGG)


    • Median duration of response: 18 months


    • Manageable safety profile, mostly Grade 1–2 adverse events


    • Convenient once‑weekly oral dosing (liquid or tablet)



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