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.
Roche in July presented data from a late-stage trial that showed Gazyva delayed disease progression in patients with CLL longer than its top-seller Rituxan. Final data from the study is expected to be presented at the American Society of Hematology’s annual meeting in December.