Astellas gets FDA green light for Xospata
Astellas Pharma has received the Food and Drug Administration’s nod for Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory, or resistant to treatment Acute Myeloid Leukemia, or AML with an FLT3 mutation as detected by an FDA-approved test.
Xospata is an oral therapy and the first and only FLT3-targeting therapy to be approved by the FDA for this population.
The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed with AML in the U.S. AML has been associated with various genetic mutations.
"Xospata offers new hope to patients for whom the treatment path forward is unclear," Astellas senior vice president and global therapeutic area head, oncology development, Steven Benner said. "For the first time, people with relapsed or refractory FLT3 mutation-positive AML have an FDA approved FLT3-targeting treatment available to them. The approval of Xospata is also a proud, landmark moment for our oncology program and marks the first approval of a medicine that will be the cornerstone of our new presence in blood cancers."
Xospata is an oral therapy and the first and only FLT3-targeting therapy to be approved by the FDA for this population.
The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed with AML in the U.S. AML has been associated with various genetic mutations.
"Xospata offers new hope to patients for whom the treatment path forward is unclear," Astellas senior vice president and global therapeutic area head, oncology development, Steven Benner said. "For the first time, people with relapsed or refractory FLT3 mutation-positive AML have an FDA approved FLT3-targeting treatment available to them. The approval of Xospata is also a proud, landmark moment for our oncology program and marks the first approval of a medicine that will be the cornerstone of our new presence in blood cancers."