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Tuesday, 08/06/2024 6:15:45 PM

Tuesday, August 06, 2024 6:15:45 PM

Post# of 827910
The next approval will be DCVax-L!

FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation?utm_medium=email&utm_source=govdelivery

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, Switzerland’s Swissmedic, and Israel’s Ministry of Health (IMoH). The application reviews are ongoing at the other regulatory agencies.



INDIGO: Vorasidenib Offers Patients With IDH-Mutant Low-Grade Glioma a Means to Delay Chemotherapy and Radiotherapy
https://dailynews.ascopubs.org/do/indigo-vorasidenib-offers-patients-idh--mutant-low-grade-glioma-means-delay

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