Abstract
The FDA has approved Novartis’s Rydapt (midostaurin) in combination with chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, diagnostic from Invivoscribe Technologies.
“Rydapt is the first targeted therapy to treat patients with AML, in combination with chemotherapy,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The ability to detect the gene mutation with a diagnostic test means doctors can identify specific patients who may benefit from this treatment.”
Rydapt, a kinase inhibitor, works by blocking enzymes that promote cell growth. If the FLT3 mutation is detected in blood or bone marrow samples using the LeukoStrat CDx FLT3 Mutation Assay, the patient may be eligible for treatment with Rydapt in combination with chemotherapy.