Novartis's Rydapt approved for AML, systemic mastocytosis in EU

In September, the European Commission approved Rydapt midostaurin (CGP 41251, PKC412) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat acute myelogenous leukemia (AML), advanced systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia.

Rydapt in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy is indicated for newly diagnosed AML patients with the FMS-like tyrosine kinase 3 (FLT3; CD135) mutation , and as a single-agent maintenance therapy following a complete response to chemotherapy. Rydapt is approved as monotherapy for systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia...