(Reuters) - The U.S. Food and Drug Administration on Wednesday approved a blood cancer treatment from Japan’s Astellas Pharma Inc, making it the first targeted therapy to treat patients with a certain mutation.
The treatment, Xospata, was approved for patients with acute myeloid leukemia (AML) with a FLT3 mutation, whose cancer has relapsed or proved treatment-resistant.
The drug, taken once a day in tablet form, will have a wholesale acquisition cost of $22,500 for a month’s supply, Astellas said.
“Astellas intends to commercialize this product globally without a partner,” Steven Benner, a senior vice president at the company, told Reuters.
The drug 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.
As an oral therapy, it offers the potential for patients to be treated outside of the hospital, Astellas said.
The company is also developing a treatment for bladder cancer and expects to seek approval for the drug next year.
“Oncology is the largest therapeutic area within development for Astellas, (and) accounts for over half of the company’s development budget,” Benner said.
Xospata’s approval was based on an interim analysis of a late-stage trial, and the drug will be made available to patients that largely depend on 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