FDA approval for GSK

GSK

The FDA have approved GlaxoSmithKline's drug Arzerra as a treatment for chronic lymphocytic leukemia, a slowly progressing cancer of the blood and bone marrow.

The news of the approval comes as part of the US Food and Drug Adminstration's (FDA) accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. According to reports on Reuters pertaining to the accelerated process, products may recieve this kind of approval boased on a "surrogate endpoint" - for example, the reduction in the size of a tumour or the decrease in the number of cancerous white cells.

As such, the approval of Arzerra - which has been approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy - illustrates the FDA's commitment to using the accelarated approval process to help those patients who otherwise have limited therapeutic options.

Diagnosis

Arzerra's approval significantly marks a brighter future for CLL patients. The disease, which primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body's immune system, kills about 4400 people each year.

The drug, a monoclonal antibody, binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

However, because of the drug was approved through the accelerated approval process further studies of the drug are now required. As a part of this process GSK is already conducting clinical trials to prove that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

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