The US FDA has in a recent move granted Roche’s
Gazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis.
Gazyva (obinutuzumab) is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Classified as a "monoclonal antibody", Gazyva is a CD20-directed cytolytic antibody. The drug is recommended in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). Furthermore, Gazyva is also indicated in combination with bendamustine for the treatment of of follicular lymphoma (FL) with a prior rituximab-containing therapy regimen.
The decision for granting a Breakthrough des...
