Posted by Michael Wonder on 20 Jul 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukeamia who have a certain genetic mutation
20 July 2018 - The U.S. FDA today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.
This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.
The FDA granted this application fast track and priority review designations. Tibsovo also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
