FDA Breakthrough granted for Roche’s Gazyva

Roche has announced that Gazyva (obinutuzumab) has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for adults with lupus nephritis. The designation was based on the Phase II NOBILITY study, in which the drug in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo and standard of care alone in achieving complete renal response at one year. The trial also met its secondary endpoints, showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo. Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Sandra Horning, Roche’s chief medical officer and head of global product development, reminded that “new treatment options are needed for lupus nephritis”, and explained that the company is “committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase III trial next year.”