Midostaurin approved to treat AML, SM in Europe

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Midostaurin (Rydapt) capsules
Photo courtesy of Novartis
The European Commission has approved the multi-targeted kinase inhibitor midostaurin (Rydapt®) to treat acute myeloid leukemia (AML) and 3 types of advanced systemic mastocytosis (SM). Midostaurin is approved to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. In these patients,... [Read Article]
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CHMP advocates refusal of application for SM drug

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Mast cells
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended refusal of the marketing authorization for masitinib (Masipro). Masitinib is a tyrosine kinase inhibitor being developed by AB Science to treat adults with smoldering or indolent severe systemic mastocytosis (SM). To support the application for masitinib, AB... [Read Article]
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Application for pegfilgrastim biosimilar withdrawn

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Vials of drug
Mylan S.A.S. has withdrawn the European marketing authorization application for its pegfilgrastim biosimilar Fulphila, according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Fulphila was intended to be used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving cytotoxic... [Read Article]
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FDA approves drug to treat relapsed FL

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Copanlisib (Aliqopa)
PRNewsfoto/Bayer
The US Food and Drug Administration (FDA) has granted accelerated approval to copanlisib (Aliqopa), an intravenous PI3K inhibitor developed by Bayer. The drug is now approved to treat adults with relapsed follicular lymphoma (FL) who have received at least 2 prior systemic therapies. Copanlisib received accelerated approval from the FDA... [Read Article]
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