In partnership with Syndax Pharmaceuticals we are expanding access to the Syndax’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.
Anjali Ganguli, Ph.D., Chief Strategy Officer at Syndax Pharmaceuticals, stated:
“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. 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.”
Patrick Jordan, Chairman at WODA, added:
“This collaboration underscores WODA’s mission to bridge the access gap for patients with rare and life-threatening diseases. 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 treatment options and a poor prognosis.
The program will be administered by WODA, a leader in enabling patient access to medicines in over 150 countries on six continents. WODA will provide Revuforj to healthcare providers on a named patient basis through its network of members. The program will be conducted in accordance with local regulatory and ethical frameworks to ensure compliant, patient-focused distribution.
Physicians and healthcare professionals may inquire about program details by contacting medinfo@syndax.com. Patients and caregivers seeking information should contact their physician.
The full press release is available here: ir.syndax.com