Novartis: FDA Approves Rydapt To Treat FLT3-mutated Acute Myeloid Leukemia

(RTTNews) - Novartis (NVS) announced the US FDA has approved Rydapt (midostaurin) for two indications. The first indication is for the treatment of acute myeloid leukemia in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive, as detected by an FDA-approved test, in combination with chemotherapy. Rydapt is also approved to treat adults with advanced systemic mastocytosis, which includes aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia.

The FDA approval is based on the Phase III RATIFY clinical trial, which was conducted in collaboration with the Alliance for Clinical Trials in Oncology and its 13 contributing international cooperative groups. Worldwide filings for Rydapt are currently underway.