The FDA has approved a new drug called Gazyva (obinutuzumab) for adults with chronic lymphocytic leukemia (CLL) who have not yet received treatment. It is approved for use in combination with another drug called chlorambucil. CLL is a type of cancer that affects white blood cells and is the most common leukemia in adults.
Gazyva is a lab-made antibody that targets a protein called CD20 found on certain immune cells, including the cancer cells in CLL. By binding to CD20, it helps the immune system destroy those cells. The approval is based on how the drug works, not on data from a clinical trial that directly compared it to other treatments.
The recommended dose involves a split first dose, with 100 mg on day 1 and 900 mg on day 2 of the first cycle, followed by additional doses on days 8 and 15, and then once per cycle for cycles 2 through 6. It is given only as an intravenous infusion. Patients must receive premedication to help prevent infusion reactions and tumor lysis syndrome, a condition where cancer cells break down too quickly.
The label includes warnings for infusion-related reactions and tumor lysis syndrome, so monitoring and supportive care are important. This approval offers another option for some patients, but it is not right for everyone. If you or a loved one has CLL, talk with your doctor about whether this treatment might be appropriate.
