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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.
- Program will expand access in certain regions where Revuforj is not available commercially, as permitted by local regulations - - Program will be launched
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Program will expand access in certain regions where Revuforj is not available commercially, as permitted by local regulations - - Program will be launched in parts of Eurasia, Central and Southeast Europe, Israel, the Middle East and Turkey, Latin America, and Africa - NEW YORK, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX) and the World Orphan Drug Alliance (WODA) today announced a collaboration to expand access to the Company’s first-in-class menin inhibitor, Revuforj® (revumenib), through a Managed Access Program. This program enables physicians to prescribe Revuforj to appropriate patients outside the U.S. where the drug is not approved but access to novel medicines is permitted by local regulations and where funding can be secured. The program is being launched in parts of Eurasia, Central and Southeast Europe, Israel, the Middle East and Turkey, Latin America, and Africa. “We are thrilled to partner with WODA to begin expanding access to Revuforj around the globe, further advancing our mission to transform care for cancer patients,” said Anjali Ganguli, Ph.D., Chief Strategy Officer at Syndax Pharmaceuticals. “In addition to providing a pathway for patients to access Revuforj in regions where it would otherwise be inaccessible, this program will also allow more physicians to gain valuable firsthand experience with the medicine, supporting our long-term goal to establish Revuforj as a standard of care treatment globally.” “This collaboration underscores WODA’s mission to bridge the access gap for patients with rare and life-threatening diseases,” said Patrick Jordan, Chairman at WODA. “Our alliance model enables us to reach patients in regions where access to innovative therapies, including in oncology, remains a critical challenge.” In the U.S., Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients one year and older. Revuforj is also FDA approved for the treatment of R/R acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. These are difficult-to-treat blood cancers associated with limited treatme...