Thursday, December 4, 2014

Drug for rare form of leukemia given FDA nod

Amgen's blinatumomab allows T-cells to
attach to an immature B-cell and destroy it.
CANCER DIGEST – Dec. 4, 2014 – The FDA has approved Blincyto (blinatumomab) to treat patients with a rare type of leukemia, called Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL).

Precursor B-cell ALL is a rapidly growing type of leukemia in which the bone marrow makes too many immature B-cells that are not yet functional in the immune system. The National Cancer Institute estimates that 6,020 Americans will be diagnosed with this form of leukemia and 1,440 will die from it in 2014. The Philadelphia chromosome is an abnormality that sometimes occurs in the bone marrow cells of leukemia patients and is linked to chronic myelogenous leukemia (CML).

Blincyto is the first FDA-approved  drug that engages the body’s T-cells, a type of white blood cell that attacks and destroys leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most immature B-cells, and CD3, a protein on T-cells. It is intended for patients whose cancer returned after treatment (relapsed) or did not respond to previous treatment (refractory).

The safety and effectiveness of Blincyto were evaluated in a clinical study involving 185 adults with Philadelphia chromosome-negative relapsed or refractory precursor B-cell ALL. All participants were treated with Blincyto for at least four weeks. Results showed 32 percent of participants had complete remission, meaning there was no evidence of disease for 6.7 months.

The FDA granted Blincyto breakthrough therapy designation, priority review and orphan product designation because the maker, Amgen, Inc. had demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies.

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