FDA Grants Frontline Obinutuzumab Priority Review for Follicular Lymphoma

August 28, 2017 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with follicular lymphoma, according to Genentech, the manufacturer of the therapy. The sBLA is based on data from the phase III GALLIUM study, in which combining obinutuzumab with chemotherapy in the first-line setting … (leggi tutto)