(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. 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.
The Swiss drugmaker is hoping its newer drug will help offset expected lost sales of its $7 billion-a-year Rituxan, after it loses U.S. patent protection in Europe late this year. Rituxan, also known as MabThera, is an antibody against white blood cells that have the so-called CD20 protein on their surface. It is used to treat lymphomas, leukemias, transplant rejection and rheumatoid arthritis.
Reporting by Ransdell Pierson; editing by Matthew Lewis