Blincyto Approval Expanded for Specific Leukemia
THURSDAY, March 29, 2018 -- The U.S. Food and Drug Administration says it has expanded approval for Blincyto (blinatumomab) to include adults and children with B-cell precursor acute lymphoblastic leukemia who are in remission but who still have minimal residual disease (MRD).
MRD describes the presence of cancer cells in the body, but below levels that can be seen in a microscope, the agency said Thursday in a news release. This condition raises a person's chances that the cancer will come back.
"Because patients who have MRD are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukemia cells may help keep the cancer in remission longer," said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence.
The affected type of leukemia is an aggressive cancer in which the bone marrow makes too many B-cell lymphocytes, an immature white blood cell. Nearly 6,000 people in the United States are projected to be diagnosed with the disease this year, and almost 1,500 will die from it, the National Cancer Institute estimates.
Blincyto was first approved in 2014 to treat a different type of leukemia called Philadelphia chromosome-positive ALL. The drug's common side effects include infections, fever, headache, infusion-site reactions and low blood cell levels.
The drug is produced by Thousand Oaks, Calif.-based Amgen Inc.
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Posted: March 2018
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