publication date: Sep. 22, 2017
Drugs and Targets Novartis’s Rydapt gets EU approval for AML and SM indications
The European Commission approved Rydapt (midostaurin) for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive.
The agent was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia.
The approval follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use in July 2017 and applies to all 28 EU member states, plus Iceland, Liechtenstein, and Norway.
Rydapt represents the first and only targeted therapy for FMS-like tyrosine kinase 3-mutated AML and the only treatment for three subtypes of SM, collectively known as advanced SM, in the EU, all of which have limited life expectancy and few treatment options.
Rydapt, sponsored by Novartis, represents the first major advancement for the treatment of patients with newly diagnosed FLT3-mutated AML in more than 25 years.
For newly diagnosed FLT3-mutated AML, the approval is based on data from the RATIFY (CALGB 10603 [Alliance]) trial, which was conducted in collaboration with the Alliance for Clinical Trials in Oncology and 13 international cooperative groups.
RATIFY is … Continue reading Novartis’s Rydapt gets EU approval for AML and SM indications
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