FDA approves Roche leukemia drug Gazyva

(Reuters) – U.S. regulators said on Friday they approved a new treatment from Roche Holding AG for patients with chronic lymphocytic leukemia (CLL) who have not previously been treated for one of the most common forms of blood cancer. The U.S. Food and Drug Administration said the new drug, Gazyva (obinutuzumab), works by helping certain immune system cells to attack cancer cells, and is meant to be used with a standard treatment for the disease called chlorambucil. It is the first drug having a "breakthrough therapy" designation to win FDA approval, the agency said. Final data from the study is expected to be presented at the American Society of Hematology's annual meeting in December.