Vyxeoshas been approved by the Food and Drug Administration (FDA) as medication for adults with 2 forms of acute myeloid leukemia (AML), namely, newly analyzed AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML). Vyxeos is a fixed blend of chemotherapy drugs cytarabine and daunorubicin.
Richard Pazdur said, “This is the first permitted treatment precisely for patients with particular kinds of high-risk AML.” AML is a speedily progressing cancer that develops in the bone marrow and causes a rise white blood cells’ number in the bloodstream. The National Institutes of Health’s National Cancer Institute evaluates that roughly 21,380 individuals will be analyzed, this year, with AML; around 10,590 AML patients, in 2017, will die of the disease.
T-AML arises as a radiation or chemotherapy complication in about 8–10% of all patients medicated for cancer in an average of 5 years post-treatment. AML-MRC is specified by a history of particular blood disorders and other major mutations in cancer cells. The life expectancies of the patients with AML-MRC or t-AML are very low.
Vyxeos’ efficacy and safety were examined in newly diagnosed AML-MRC or t-AML patients (n=309), who were randomized to obtain distinctly administered cytarabine & daunorubicin treatments or Vyxeos. The test evaluated how long patients survived from the date they initiated the study (overall survival). The study demonstrated that patients who had Vyxeos lived longer compared to who had distinct treatments of cytarabine and daunorubicin (median overall survival 9.56 versus 5.95 months).
Vyxeos’ common side-effects included hemorrhage, fever with low count of white blood cells, tissue swelling (edema), rash, nausea, diarrhea, inflammation of the mucous membranes, musculoskeletal pain, constipation, abdominal pain, fatigue, headache, shortness of breath, decreased appetite, cough, lung infection, abnormal heart rhythm, blood infection, sleep disorders, vomiting, and chills.
Vyxeos should not be taken by individuals who have a history of severe hypersensitivity to cytarabine, daunorubicin, or any constituent of the formulation. Patients having Vyxeos should be observed for reduced cardiac function and hypersensitivity reactions. The drug has been related with fatal or serious bleeding events. Breastfeeding or pregnant women should not have Vyxeos as it may cause damage to a newborn baby or developing fetus.Daunorubicin has been linked to necrosis on drug leaks into the subcutaneous tissue and skin from the intravenous infusion.
This application was granted Breakthrough Therapy and Priority Review designations by FDA. Vyxeos also obtained the Orphan Drug designation that offers incentives to encourage and assist the drug development for rare diseases. The FDA approved the authorization to Jazz Pharmaceuticals of Vyxeos.