Nov 1 U.S. regulators said on Friday they
approved a new treatment from Roche Holding AG for
patients with chronic lymphocytic leukemia who have not
previously been treated for the blood and bone marrow disease.
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. The new
designation indicates the medicine may offer substantial
improvement over standard treatments for patients with serious
or life-threatening diseases.