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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.

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