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Novartis Drug Rydapt Gets EU Approval For Newly Diagnosed FLT3-mutated AML

Novartis said that the European Commission approved Rydapt (midostaurin) for two indications in rare, hard-to-treat cancers.

Rydapt is approved 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 (AML) who are FLT3 mutation-positive.

It was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.

The approval follows a positive opinion issued by the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on July
20, 2017 and applies to all 28 EU member states, plus Iceland, Liechtenstein and

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.

The study showed a 23% reduction in the risk of death with Rydapt plus standard chemotherapy compared with placebo plus standard chemotherapy. Median overall survival of 74.7 months and 25.6 months, respectively (hazard ratio [HR] = 0.77, 95% confidence interval [CI], 0.63, 0.95; one-sided p=0.0078).

by RTT Staff Writer

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