FDA approves Novartis’ leukemia treatment
The U.S. Food and Drug Administration approved Novartis AG’s Rydapt as an initial treatment for acute myeloid leukemia (AML) as well as certain other blood disorders, the agency said on Friday.
AML is a cancer that forms in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells.
Rydapt is approved to be used along with chemotherapy to treat adults newly diagnosed with AML and carrying a specific genetic mutation called FLT3, the FDA said.
The drug is meant to be used in tandem with a companion diagnostic designed to detect the FLT3 mutation.
About 21,380 new cases of AML will be diagnosed in 2017 and some 10,590 patients will succumb to the disease this year, according to estimates by the American Cancer Society.
Rydapt was also approved to treat adults with certain types of rare blood disorders, including aggressive systemic mastocytosis and mast cell leukemia, the FDA said.
(Reporting by Natalie Grover in Bengaluru; Editing by Savio D’Souza)