……….. catching upon FDA approvals
The FDA recently approved a new ORAL specialty therapy, Revuforj (revumenib) from Syndax Pharmaceuticals, for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.
Revuforj is the first and only menin inhibitor approved for the condition.
The therapy was granted Orphan Drug status.
The company priced Revuforj at $39,500 per month, or $474,000 annually.
Revuforj was approved with a Black Box warning for differentiation syndrome, a potentially fatal condition in which leukemia cells rapidly release cytokines.
CLICK HERE to access prescribing information
Syndax announced that Revuforj launched through a network of specialty distributors and specialty pharmacies and full availability all doses by Q2-2025. An oral solution will be available through an expanded access program to allow for dosing of patients who weigh less than 40 kg.
As of this date only Onco360 has confirmed its selection to be an authorized dispensing pharmacy for Revuforj.
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