The FDA has approved an IBTROZI label update incorporating a 49.7-month median duration of response from the TRUST-I study in TKI-naïve ROS1-positive NSCLC.
FDA Fast Track designation could increase regulatory interaction around safusidenib while Nuvation Bio tests the IDH1 inhibitor across several glioma settings.
Rare cancer drugs need more than FDA approval. Nuvation Bio’s Ibtrozi test now shifts to U.S. supply reliability and launch execution.
Nuvation Bio now controls safusidenib globally. Read why the Japan deal matters for IDH1-mutant glioma, SIGMA, and the post-vorasidenib market.