The US Food and Drug Administration (FDA) has granted approval for Azerra, a new treatment for chronic lymphocytic leukaemia (CLL) manufactured by GlaxoSmithKline (GSK).
Azerra was awarded approval under the FDA's accelerated approval process as an important new treatment for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.
Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease, which affects the body's B-cells.
Arzerra is a monoclonal antibody that binds to a specific protein found on the surface of normal and malignant B cells, making the cells more susceptible to immune system attack.
GSK is conducting clinical trials to confirm that Arzerra delays the progression of the disease when used in addition to standard chemotherapy.
Arzerra's effectiveness has already been evaluated in 59 patients with CLL whose disease no longer responded to the available therapies. The product's safety was evaluated in 181 patients in two studies in patients with cancer.