US FDA approved new medicine Rydapt that contains midostaurin as an active pharmaceutical ingredient for the treatment of acute myeloid leukemia in those adults who have fms like tyrosine kinase 3 (FLT-3) mutation. FDA indicated the usage of this drug along LeukoStrat CDx FLT3 ( Mutation detection Assay used to detect the FLT3 mutation in patients with AML).
Acute myeloid leukemia (AML) is a type of cancer of myeloid cells characterized by instant proliferation of abnormal white blood cells (WBC's). Mortatlity rate of Acute myeloid leukemia (AML) is 1.2% of cancer deaths in the United States. Though, it is rare disease but middle age group is most commonly affected by AML. Acute myeloid leukemia (AML) has several types It is presumed that regular exposure to chemical agents aromatic compounds like benzene, ionizing agents, radicals, halogens and oxidative agents are major risk factors that play important role in pathogenesis of Acute myeloid leukemia (AML). Other risk factors include genetic predisposition, blood disorders, viral infections etc.
Symptoms of Acute myeloid leukemia (AML) include flu like symptoms, restlessness, mild fever, weight loss, loss of appetite, gums swelling, enlarged spleen, internal hemorrhage, petechiae, frequent infections. In some cases Lymph node swelling may also occur but is rare. Patient having age less than 50 years have more survival rate than those having age more than 60 years.
Rydapt/midostaurin Side effects
According to data provided by US FDA this drug exhibit following side effects during clinical trials
- Drug induced neutropenia
- Mucous membrane swelling
- abdominal pain
- muscular pain
- shortness of breadth
- Upper respiratory tract infections
- Loss of appetite
Rydapt/midostaurin Uses or Patient Information
US FDA assigned Rydapt as breakthrough therapy for the treatment of acute myeloid leukemia (AML) in those patients in which fms like tyrosine kinase 3 (FLT-3) mutations have identified. This drug can be used with other chemotherapeutic agents. Additionally, US FDA also indicated the usage of this drug with LeukoStrat CDx FLT3 ( Mutation detection Assay used to detect the FLT3 mutation in patients with AML).
Rydapt/midostaurin is formulated as 25mg tablet for oral administration. It is dosage frequency is 50mg orally (PO) twice a day (BID). This drug may also be used in combination with other chemotherapeutic agents like cytarabine and daunorubicin.