FDA gives green signal to Roche's obinutuzumab

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.