FDA approves Gazyva – a new treatment of chronic lymphocytic leukaemia

On 1 November 2013, Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) accepted Gazyva (obinutuzumab), also known as GA101. It is designed to be used with chlorambucil chemotherapy for the treatment of chronic lymphocytic leukemia (CLL). Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. Now, it remains under review by the European Medicines Agency, whose recommendation is usually followed by the the European Commission, the decision-maker for drug marketing across the European Union.

B-lymphocyte antigen CD20 is expressed on the surface of all B-cells during all stages of its development except the first and the last. Gazyva is a new monoclonal antibody that attach to CD20. Therefore, it helps certain immune system cells to attack cancer cells.

Chronic Lymphocytic Leukemia (CLL)

The prevalent  form of  blood cancer. According to the National Cancer Institute, 15,680 new cases and 4,580 deaths are expected in 2013 in America. The average age of diagnosis is 71-74. Most people are diagnosed without symptoms as the result of a routine blood test that returns a high white blood cell count.

CLL is generally considered incurable. It progresses slowly in most cases. Treatment is focused on controlling the disease and its symptoms. 

Gazyva Efficacy In CLL

Phase III clinical data proved that Gazyva in combination with chlorambucil chemotherapy helped people with CLL live longer without the disease getting worse than chlorambucil chemotherapy alone.

According to the Genentech, Overal Response Rate (ORR) after the treatment with Gazyva + clb increased from 32.1% to 75.9% versus clb alone. What is important, 27.8% of  patients receiving Gazyva had a complete response which means all evidence of the cancer is gone for a period of time. In the case of patients receiving chlorambucil alone it is only 0.9%.

GA 101 Side Effects

The most common side effects observed in participants treated with Gazyva were infusion reactions, low blood cell counts, fever, cough, muscle and joint pain. Nonetheless, there are some serious side effects possible including  Progressive Multifocal Leukoencephalopathy (PML) and Tumor Lysis Syndrome (TLS). What is more, if a patient have had hepatitis B or is a carrier of HBV, receiving Gazyva could cause the virus to become an active infection again.