FRIDAY, April 28, 2017 (HealthDay News) — Rydapt (midostaurin) has been approved by the U.S. Food and Drug Administration, in combination with chemotherapy, to treat adults with acute myeloid leukemia (AML) who have the FLT3 mutation, the agency said in a news release.
The National Cancer Institute estimated that 19,930 people would be diagnosed with AML in 2016, with 10,430 projected to die of the disease, the FDA said.
Midostaurin is a kinase inhibitor. It was evaluated in a randomized trial of 717 patients who had not been treated previously for AML. Common adverse effects included febrile neutropenia, nausea, headache, and musculoskeletal pain. Patients who experience pulmonary toxicity should discontinue use of the drug, the FDA said. In addition, the agency said women who are pregnant or nursing should not take midostaurin, which could harm a developing fetus or newborn.
A companion diagnostic test was simultaneously approved to detect the FLT3 mutation.
Approval of Rydapt was granted to the Swiss company Novartis Pharmaceuticals.