FDA Approves Blincyto for a Type of Acute Lymphoblastic Leukemia (ALL)

The US Food and Drug Administration (FDA) has approved Blincyto (blinatumomab) to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL). It’s for people who have this type of cancer and didn’t get better with treatment, or who got better but then had a recurrence.

The drug was approved 5 months ahead of its goal. The FDA granted it breakthrough therapy designation, priority review, and orphan product designation, all programs designed to make drugs available faster when they have the potential to significantly improve treatment for a rare or serious disease.

Philadelphia chromosome-negative precursor B-cell ALL is a fast-growing type of cancer that starts in the white blood cells of the bone marrow. Blincyto is a kind of immunotherapy, a drug that uses the body’s own immune system to fight cancer. It’s given as an infusion in the vein. Once inside the body, the drug acts as a link to bring the leukemia cells into contact with immune cells, which is thought to cause the immune system to attack the leukemia.

The FDA based its approval on the results of a clinical trial of 185 adults with Philadelphia chromosome-negative precursor B-cell ALL that did not respond to treatment with other drugs, or that came back after treatment with other drugs. Everyone in the trial received Blincyto for at least 4 weeks, and about ⅓ (32%) experienced a complete remission – no evidence of cancer – for an average of about 6.7 months.

The most common side effects from the drug were fever, headache, swelling, infection, nausea, low potassium, fatigue, constipation, diarrhea, and tremor. Less common, but more serious side effects included problems with low blood pressure and difficulty breathing at the start of treatment, and a short period of trouble thinking and other problems with the nervous system.

Blincyto is marketed by Amgen, Inc.

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