Novartis: leukemia drug gets positive CHMP opinion.
(CercleFinance.com) - Novartis said the advisory committee of European health regulators has recommended approval of Rydapt for the treatment acute myeloid leukemia (AML) by the European Commission.
The Swiss drugmaker today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending approval of Rydapt for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.
Rydapt was also recommended for approval as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The Swiss drugmaker today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending approval of Rydapt for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.
Rydapt was also recommended for approval as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.
Copyright (c) 2017 CercleFinance.com. All rights reserved.