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Syndax and World Orphan Drug Alliance to Launch a Multi-Regional Managed Access Program, Expanding Access to Revuforj® (revumenib) Outside the U.S.
Globenewswire· 2026-01-07 12:00
Core Insights - Syndax Pharmaceuticals has partnered with the World Orphan Drug Alliance (WODA) to expand access to its first-in-class menin inhibitor, Revuforj, through a Managed Access Program in regions where the drug is not commercially available [1][2] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on advancing innovative cancer therapies, including Revuforj and Niktimvo [24] - Revuforj is FDA approved for treating relapsed or refractory acute leukemia with specific genetic mutations in both adult and pediatric patients [5][7] Collaboration Details - The Managed Access Program will allow physicians to prescribe Revuforj to patients in regions such as Eurasia, Central and Southeast Europe, Israel, the Middle East, Turkey, Latin America, and Africa [1][2] - WODA will administer the program, ensuring compliance with local regulations and ethical frameworks [3] Treatment Indications - Revuforj is indicated for patients with relapsed or refractory acute leukemia characterized by KMT2A translocation or NPM1 mutation, conditions that have limited treatment options and poor prognosis [2][5] Clinical Development - Ongoing and planned clinical trials for Revuforj include studies in combination with standard therapies for newly diagnosed patients with specific types of acute myeloid leukemia [6]