(Reuters) – The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals’ drug for the treatment of adult and pediatric patients with a type of blood cancer, sending the company’s shares up 3% in after-hours trading.
The drug revumenib, sold under the brand name Revuforj, is used to treat acute leukemia with a KMT2A translocation, which are chromosomal rearrangements that involve the KMT2A gene and are found in about 10% of acute leukemia patients.
Revuforj belongs to a new class of drugs called menin inhibitors which prevent the binding of a protein called menin to another protein called MLL, which stops the activation of proteins that can cause cancer cells to grow.
The approval was based on an early- to mid-stage trial with 104 patients, where the drug showed 21% complete remission with a partial recovery in the levels of specific blood cells.
Leukemia affects more than 60,000 people in the United States annually, according to the National Institutes of Health.
This is the second FDA nod for Syndax this year after the agency approved the company and partner Incyte’s drug Niktimvo in August for patients with chronic graft-versus-host disease, a potentially fatal immune reaction that could occur after a stem cell transplant.
Syndax expects that the 110 mg and 160 mg tablets of Revuforj will be available for order in the United States this month.
(Reporting by Christy Santhosh in Bengaluru; Editing by Maju Samuel)
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