US FDA approves Syndax's blood cancer drug

Syndax Pharmaceuticals

15/11/2024 23:24

Nov 15 (Reuters) - The U.S. Food and Drug Administration
on Friday approved Syndax Pharmaceuticals'  SNDX.O  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  INCY.O  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)
 ((Christy.Santhosh@thomsonreuters.com;))