Novartis AG receives EU approval for Rydapt
- Co announced 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 who are FLT3 mutation-positive.
- It was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia
- The approval is based on data from the RATIFY
- Significant overall survival benefit seen with Rydapt, the first targeted treatment for newly diagnosed FLT3-mutated AML approved in the EU
- As the first and only therapy for advanced SM in the EU, Rydapt offers a new treatment option for patients with this group of rare and life-threatening diseases
- Approval based on data from largest landmark trials in AML and advanced SM to date; first major development in targeted AML treatment in more than 25 years
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