(Reuters) – Japan’s Astellas Pharma Inc on Wednesday received approval from the U.S. Food and Drug Administration for its blood cancer treatment, according to the regulator’s website bit.ly/2SjB8CL.
The oral drug, Xospata, was approved to treat patients with acute myeloid leukemia (AML) with a FLT3 mutation, whose cancer has relapsed or proved treatment-resistant.
“Astellas intends to commercialize this product globally without a partner,” Steven Benner, a senior vice president at the company, told Reuters.
The drug is a targeted therapy that will be able to treat about 30 to 40 percent of the over 19,000 new patients that are expected to be diagnosed with AML in the United States this year, the company said.
The approval was based on an interim analysis of a late-stage trial, and makes the drug the first approved for patients with the FLT3 mutation who are currently largely treated with chemotherapy, Astellas said.
The FDA has authorized Xospata’s use in AML patients whose mutation has been diagnosed with a certain companion test.
Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing by Shailesh Kuber
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