FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Combination Treatment for Acute Myeloid Leukemia

May 5, 2017
A A

The FDA has approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia who have a specific genetic mutation called FLT3.

The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay.

Rydapt is a kinase inhibitor that blocks several 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.

Rydapt was also approved for adults with certain types of rare blood disorders: aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukemia.

View today's stories