(Obinutuzumab) Gazyva

Gazyva (obinutuzumab) is an antineoplastic agent, anti-CD20 monoclonal antibody. For individuals who have NHL who receive obinutuzumab alone or combined with chemotherapy, the evidence includes RCTs. Relevant outcomes are overall survival, change in disease status, quality of life, and treatment-related morbidity. Obinutuzumab was approved by the Food and Drug Administration for the treatment of FL in patients who have relapsed or are refractory to a rituximab-containing regimen; the drug was also approved for use in combination with chlorambucil for previously untreated CLL in combination with bendamustine. These indications are based on positive results in phase 3 trials that compared combination therapy with monotherapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.