United States: On Friday, the US Food & Drug Administration (FDA) granted the Market approval to Syndax Pharmaceuticals drug known as Revumenib (branded Revuforj) for acute leukemia involving KMT2A translocation. This genetic mutation is seen in about 10% of acute leukemia patients. After the announcement, shares of Syndax increased by 3% in after-market trading.
How Revuforj Works
Revuforj belongs to a novel drug class called menin inhibitors. These drugs block the interaction between the menin protein and MLL protein, disrupting cancer-causing pathways. FDA approval was based on a trial involving 104 patients, where 21% achieved complete remission, with partial recovery in certain blood cell counts, as reported by Reuters.
The Ongoing Fight Against Leukemia
Blood cancer that is leukemia impacts more than 60 individuals in America per every one thousand citizens as stated by the National Institutes of Health. Its approval can emblematically be seen as a step forward in combating this constant health issue by Revuforj.
Second FDA Approval for Syndax in 2024
This is Syndax’s second FDA approval this year. In August, its partnered drug Niktimvo received approval for chronic graft-versus-host disease—a severe complication following stem cell transplants, as reported by Reuters.
Availability of Revuforj
Syndax announced that Revuforj, available in 110 mg and 160 mg doses, will be accessible in the U.S. later this month.