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Phase III Survival Benefit Boosts Imbruvica’s Profile Ahead Of FDA’s CLL Decision

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

RESONATE study is halted after Pharmacyclics/Janssen’s Imbruvica shows a survival benefit as a monotherapy compared to GlaxoSmithKline’s Arzerra. Analysts expect results will pave way for off-label use ahead of FDA’s approval in CLL, though a delay for official clearance is possible.

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