Syndax Pharmaceuticals and World Orphan Drug Alliance Announce Managed Access Program for Revuforj® (revumenib)
NEW YORK, Jan. 07, 2026 (GLOBE NEWSWIRE) — Syndax Pharmaceuticals (Nasdaq: SNDX) has launched an initiative in collaboration with the World Orphan Drug Alliance (WODA) to provide broader access to its innovative menin inhibitor, Revuforj® (revumenib). The Managed Access Program aims to reach regions where Revuforj is not currently available commercially, enhancing treatment options for patients with specific medical needs.
Program Details and Target Regions
The Managed Access Program will focus on parts of Eurasia, Central and Southeast Europe, as well as Israel, the Middle East, Turkey, Latin America, and Africa. This strategic program allows physicians to directly prescribe Revuforj to eligible patients, even in locations where it is not yet commercially approved but is accessible according to local regulations provided funding is available.
Statements from Leadership
“We are thrilled to partner with WODA to begin expanding access to Revuforj around the globe," remarked Anjali Ganguli, Ph.D., Chief Strategy Officer at Syndax Pharmaceuticals. “This initiative not only provides a pathway for patients in underserved regions but also allows physicians to gain crucial experience with Revuforj, taking us closer to our goal of establishing it as a standard care treatment globally.”
Patrick Jordan, Chairman at WODA, added, “This collaboration underscores our mission to address the access gap for patients with rare and life-threatening diseases. Our model efficiently facilitates access to innovative oncological therapies in areas where treatment options remain critically limited.”
FDA Approval and Clinical Applications of Revuforj
In the United States, Revuforj has received FDA approval for treating relapsed or refractory (R/R) acute leukemia characterized by a lysine methyltransferase 2A gene (KMT2A) translocation, suitable for patients aged one year and older. Additionally, Revuforj is indicated for R/R acute myeloid leukemia (AML) with a vulnerable nucleophosmin 1 (NPM1) mutation within the same age group. These hematological cancers often present limited therapeutic options and poor prognoses.
Program Administration and Compliance
The Managed Access Program will be administered by WODA, which specializes in enhancing patient access to treatments in over 150 countries across six continents. Revuforj will be provided on a named-patient basis, adhering to local regulatory requirements to guarantee compliance and patient-centric distribution.
Healthcare providers interested in learning more about program specifics may contact medinfo@syndax.com, while patients and caregivers are encouraged to consult their medical professionals for further information.
About Revuforj® (revumenib)
Revuforj (revumenib) is positioned as an oral, first-in-class menin inhibitor. This therapeutic option is currently evaluated in various clinical settings, with ongoing trials exploring its efficacy in combination with standard treatments for newly diagnosed patients exhibiting NPM1m or KMT2Ar AML. Revuforj has also attained Orphan Drug Designation from both the U.S. FDA and the European Commission for several leukemia-related conditions.
Important Safety Information
Patients and healthcare professionals must be aware of significant risks associated with Revuforj, including the possibility of differentiation syndrome, QTc prolongation, and Torsades de Pointes. Healthcare providers should effectively monitor patients for these risks and manage electrolyte levels throughout treatment.