Recent Breakthrough Designated Products
Acute Myeloid Leukemia
PKC412 (midostaurin) developed by Novartis AG (NVS) is an oral, multi-targeted kinase inhibitor for acute myeloid leukemia (AML) with FLT3 mutations. It is also being studied for aggressive systemic mastocytosis/mast cell leukemia. FMS-like tyrosine kinase-3 (FLT3) is a cell-surface receptor for tyrosine kinase, which has a role in the upsurge of certain blood cell types.
The drug has positive data from the Phase 3 RATIFY (CALGB 10603) clinical trial, which was conducted in . . .