13 July 2017 - Products
FarmaMondo is pleased to announced that today Swiss Medic approved Rydapt (midostaurin) for the treatment of adult patients with newly
diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation
called FLT3, in combination with chemotherapy. The drug is approved for use
with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is
used to detect the FLT3 mutation in patients with AML
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute estimated that approximately 19,930 people would be diagnosed with AML in 2016 and 10,430 were projected to die of the disease..
Rydapt was also approved today for adults with certain types of rare blood disorders (aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukemia). Common side effects of Rydapt in these patients include nausea, vomiting, diarrhea, swelling (edema), musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, fever, headache and shortness of breath.
Novartis, who is tha MAH for Rydapt, has submitted a regulatory application for Rydapt to the European Medicines Agency (EMA) and this application is currently under review.
CONTACT FARMAMONDO TEAM FOR FURTHER INFORMATION AND DETAILS!