Leukemia Drug Approved By FDA
The U.S. Food and Drug Administration approved a new leukemia drug on Tuesday to treat a rare form of the cancer. The drug, called Bosulif, is made by Pfizer, and is approved to treat chronic myelogenous leukemia (CML), a rare form of leukemia that typically affects older adults.
CML is a blood and bone marrow disease that causes the abnormal growth of white blood cells. Most people with the disease have a specific genetic mutation, known as the Philadelphia chromosome, which causes bone marrow to make an enzyme that triggers the abnormal growth.
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Bosulif blocks the enzymes signal, which stops the out of control growth of the white blood cells.
"We are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease," Dr. Richard Pazdur, head of the FDA's cancer drugs center, said in a statement.
Bosulif is meant for people with CML who have the Philadelphia mutation have not responded to other drugs, such as Novartis' Gleevec or whose cancer has stopped responding to other treatment.
Bosulif is classified as an "orphan drug," which means that it targets a disease that affects less than 200,000 people. That classification comes with a 7-year exclusivity period, so other companies cannot manufacture generics.
CML affects approximately 26,000 Americans, with another 5,300 diagnosed annually with the disease.
Bosulif is the second cancer drug of Pfizer's to get approved this year, after the company's kidney cancer drug Inlyta was approved earlier this year as well.
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