Amgen’s Immunotherapy Blincyto Receives FDA Approval

The US Food and Drug Administration (FDA) has approved Amgen’s immunotherapy, Blincyto (blinatumomab), for treating patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). With this approval, Blinycto becomes the first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE) antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow.

Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person's immune system to fight diseases such as cancer. Blincyto is the first approved drug that engages the body's T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. It is intended for patients whose cancer returned after treatment (relapsed) or did not respond to previous treatment (refractory).

The FDA granted Blincyto breakthrough therapy designation, priority review, and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively. Blincyto is being approved more than five months ahead of the Prescription Drug User Fee goal date of May 19, 2015, the date the agency was scheduled to complete review of the application.

Blincyto is being approved under the FDA's accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. The FDA is requiring Amgen to conduct a study to verify that the drug improves survival in participants with relapsed or refractory Philadelphia-negative precursor B-cell ALL.

Source: Amgen and FDA

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