Syndax Partners With World Orphan Drug Alliance To Expand Global Access To Revuforj Via Managed Access Program

Syndax Pharmaceuticals announced a collaboration with the World Orphan Drug Alliance (WODA) to expand international patient access to Revuforj® (revumenib) through a Managed Access Program (MAP). Revuforj is a first-in-class oral menin inhibitor developed for the treatment of genetically defined acute leukemias.

The Managed Access Program enables physicians to request Revuforj for eligible patients outside the United States in regions where the therapy is not yet commercially approved but where local regulations permit access to innovative medicines and funding pathways are available. The program will initially launch across 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.”

In the United States, Revuforj is approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) acute leukemia with KMT2A gene rearrangements, as well as R/R acute myeloid leukemia (AML) with susceptible NPM1 mutations, in both adult and pediatric patients aged one year and older who have limited treatment options. These molecularly defined leukemias are associated with poor prognoses and significant unmet medical need.

“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.”

Under the collaboration, WODA will administer the program and coordinate the named patient supply of Revuforj through its global network, which spans more than 150 countries across six continents. Distribution will be conducted in compliance with local regulatory, ethical, and medical governance requirements, ensuring appropriate oversight and patient-centered access.  The Managed Access Program reflects Syndax’s commitment to broadening global access to Revuforj while regulatory review and commercialization efforts continue in international markets.