Onco-Summaries: Daily Oncology Updates at a Glance

20/08/2026

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• US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma

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US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma (Ref)

Nuvation Bio announced that the US FDA has granted Fast Track Designation to safusidenib (IDH1 inhibitor) for the treatment of IDH1‑mutant glioma. This designation enables expedited regulatory review and closer FDA engagement

Phase 2 J201 trial showed a confirmed objective response rate of 51.9%, with durable responses and a 36‑month progression‑free survival rate of 79.1%. No new safety signals emerged

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