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FDA Approves Blincyto (Blinatumomab) to Treat Rare Form of ALL

First anti-CD19 drug to receive agency approval

The FDA has given the nod to Blincyto (blinatumomab, Amgen) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.

Precursor B-cell ALL is a rapidly growing type of cancer in which the bone marrow makes too many B-cell lymphoblasts, an immature type of white blood cell. The Philadelphia chromosome is an abnormality that sometimes occurs in the bone-marrow cells of leukemia patients. The National Cancer Institute estimates that 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014.

Blincyto is the first approved drug that engages the body’s T-cells, a type of lymphocyte, to destroy leukemia cells. The drug acts as a connector between the CD19 protein, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. The treatment is intended for patients with relapsed or refractory cancer.

The FDA granted Blincyto “breakthrough therapy” status, priority review, and an “orphan drug” designation, respectively, because 1) preliminary clinical evidence indicated that the drug may offer a substantial improvement over available therapies; 2) the drug had the potential, at the time the application was submitted, to offer a significant improvement in safety or efficay in the treatment of a serious condition; and 3) the drug is intended to treat a rare disease. Blincyto was approved more than 5 months ahead of the prescription drug user fee goal date of May 19, 2015 –– the date on which the FDA was scheduled to complete its review of the application.

The efficacy and safety of blinatumomab were evaluated in a clinical study involving 185 adults with Philadelphia chromosome-negative relapsed or refractory precursor B-cell ALL. All of the participants were treated with blinatumomab for at least 4 weeks via intravenous infusion. The results showed that 32% of the participants experienced complete remission for approximately 6.7 months.

The labeling for Blincyto includes a boxed warning alerting patients and health care professionals that some clinical trial participants had problems with hypotension and difficulty breathing (cytokine-release syndrome) at the start of the first treatment, and experienced a short period of difficulty with thinking (encephalopathy) or other adverse effects in the nervous system. The most common adverse events observed in blinatumomab-treated patients included fever, headache, peripheral edema, febrile neutropenia, nausea, hypokalemia, fatigue, constipation, diarrhea, and tremor.

The FDA approved Blincyto with a risk evaluation and mitigation strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with the drug and the potential for preparation and administration errors.

Source: FDA; December 3, 2014.


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