Following discussion with FDA, safusidenib vs vorasidenib trial in grade 2 IDH1-mutant glioma cancelled
In October 2025, Nuvation Bio enrolled the first patient in the G203 study, a global, randomized study of safusidenib for maintenance treatment of high-grade IDH1-mutant glioma. Following an in-progress protocol amendment aligned on with the U.S. Food and Drug Administration (FDA), the Company plans to enroll 300 patients to support potential approval. Following discussion with the U.S. FDA, the Company has decided not to pursue a head-to-head randomized study of safusidenib against vorasidenib to support approval in non-enhancing grade 2 IDH1-mutant glioma. The Company plans to evaluate safusidenib in high-risk subgroups of low-grade IDH1-mutant glioma for which vorasidenib is not approved.
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