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+ Regulatory
Chandra Lye | May 4, 2017

Rydapt gains approval for patients with acute myeloid leukemia

A posting on the American Cancer Society's website said the Food and Drug Administration has approved a new medication for adults undergoing treatment for acute myeloid leukemia (AML).

Rydapt (midostaurin) is a drug marketed by Novartis that is designed to be used alongside chemotherapy for newly diagnosed adults that have been identified as having a gene mutation called FLT3, the posting said.

FLT3 can help cancer cells grow but Rydapt blocks proteins, called kinases, on cancer cells to prevent it from growing.

Clinical trials show that that those treated with both chemotherapy and Rydapt lived an average of eight months longer than those with chemotherapy treatment alone, the post said.

Rydapt has also been approved for patients with some blood disorders including aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia.

Side effects identified with the use of Rydapt in patients with AML are low levels of white blood cells with fever, nausea and vomiting, headache, spots on the skin due to bleeding and muscle and bone pain among others.

The side effects of the drug in those with blood disorders include nausea and vomiting, diarrhea, muscle and bone pain, abdominal pain, fatigue, constipation, fever, headache and shortness of breath.

The drug has not been recommended for pregnant or breastfeeding mothers as it may cause harm to a developing baby.

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