Genentech/Roche CLL drug GA101 gains US priority review
This article was originally published in Scrip
Executive Summary
Roche US unit Genentech won a priority review from the US FDA for the firm's biologic license application (BLA) for GA101 (obinutuzumab) as a treatment for chronic lymphocytic leukemia (CLL) – revealing the agency has set 20 December as the Prescription Drug User Fee Act action date.