Shots:

• The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery
• Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after surgery
• Study reached the 1EP of PFS & 2EP of TTNI with an mPFS of 27.7mos. vs 11.1mos. & median TTNI not attained vs 17.8mos.; tumor volume decreased by a mean of 2.5% with Voranigo & increased by a mean of 13.9% with PBO every 6mos. Data was published in the NEJM & highlighted at ASCO 2023