Syndax Pharmaceuticals has launched a multi‑regional managed access program for its menin‑inhibitor Revuforj (revumenib) in partnership with the World Orphan Drug Alliance (WODA). The program covers physicians in Eurasia, Central and Southeast Europe, Israel, the Middle East, Turkey, Latin America and Africa, allowing them to prescribe Revuforj to eligible patients even where the drug is not yet commercially approved, provided local regulations and funding arrangements permit.
Eligible patients must have relapsed or refractory acute leukemia with a KMT2A translocation or an NPM1 mutation and be at least one year of age. WODA will supply Revuforj through its named‑patient network, and local funding mechanisms—such as national health‑system reimbursement or patient‑access funds—will cover the cost. The program is designed to generate early‑stage data that can support future regulatory submissions in these regions, with a planned data‑collection window that aligns with the typical 12‑ to 18‑month period required for regulatory dossiers.
The initiative is part of Syndax’s strategy to broaden clinical experience and accelerate market entry. By collecting real‑world evidence from diverse healthcare settings, the company can demonstrate safety and efficacy in broader patient populations, potentially shortening the approval timeline and strengthening its commercial launch case. The program also builds a global patient base that can inform later‑stage trials and establish Revuforj as a standard of care once formal approvals are obtained.
Chief Strategy Officer Anjali Ganguli said the partnership “expands access to Revuforj for patients who would otherwise have no treatment options in these regions and gives physicians early exposure to a first‑in‑class therapy.” Chairman Patrick Jordan of WODA added that the alliance “bridges the access gap for rare and life‑threatening diseases, ensuring that innovative therapies reach patients worldwide.”
With Revuforj already approved in the U.S. for KMT2A‑translocated and NPM1‑mutated acute leukemias, the managed access program positions Syndax to capture a larger share of the global acute‑leukemia market. The data generated will support future regulatory submissions, potentially accelerating commercial launches and revenue growth in the covered regions.
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