Midostaurin (Rydapt®) given ‘positive opinion’ by the EMA CHMP for use in newly diagnosed FLT3+ AML patients

On 21^st July 2017, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending approval for midostaurin (Rydapt®), a multi-kinase inhibitor, for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) patients who are Fms Like Tyrosine Kinase 3 (FLT3) mutated-positive (FLT3+).¹

This positive opinion follows the recent U.S. Food and Drug Administration (FDA) approval of Rydapt® for FLT3-mutated AML on 28^th April 2017, which was reported here.

This recommendation of approval for midostaurin by the EMA CHMP was based on results from the phase III RATIFY trial (NCT00651261), which showed midostaurin in combination with standard chemotherapy significantly prolonged the survival of young adult patients with FLT3 mutated AML. More results of the study were reported here.²

The drug manufacturers, Novartis, highlighted that if Rydapt® is approved by the European Commission (EC), it will be “indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response, followed by Rydapt® single agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3 mutation-positive”.