Abstract
Designations Obinutuzumab is the fi rst drug approved with FDA’s breakthrough therapy designation. FDA can designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. FDA also granted obinutuzumab priority review because the drug demonstrated the potential to be a signifi cant improvement in safety or effectiveness in the treatment of a serious
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