The U.S. Food and Drug Administration approved the first drug to treat people with a rare form of cancer. The medication, called Jakafi, is taken two times a day to help regulate blood cells that are effected by a condition known as myelofibrosis.
What is Myelofibrosis?
Myelofibrosis is a type of chronic leukemia, a cancer that affects the blood-forming tissues in the body, according to the Mayo Clinic’s website. This serious bone marrow disorder disrupts the body’s normal production of blood cells. The result is extensive scarring in bone marrow, leading to severe anemia, weakness, fatigue, and often, an enlarged spleen and liver.
The treatment for this condition is chemotherapy, radiation and in some cases the spleen is surgically removed.
The FDA says this disease affects less than 200,000 people in the U.S.
What can the new medication do?
Several studies show patients with this condition can be relieved of some of their symptoms my using Jakafi.
“Jakafi represents another example of an increasing trend in oncology where a detailed scientific understanding of the mechanisms of a disease allows a drug to be directed toward specific molecular pathways,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“The clinical trials leading to this approval focused on problems that patients with myelofibrosis commonly encounter, including enlarged spleens and pain.”
During the study, more than a 35 percent of the participants say a reduction in spleen size and more than 50 percent saw a reduction in their symptoms including, abdominal discomfort, headaches, night sweats, itching and bone or muscle pain.
FDA approves drug quickly
According to the FDA, “Jakafi was reviewed under the FDA’s priority review program, an expedited six-month review of drugs that may offer significant advances in treatment over available therapy or that provide a treatment when no adequate therapy exists.”
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