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Pharmacyclics submits sNDA toward full Imbruvica approval in CLL

This article was originally published in Scrip

Executive Summary

Pharmacyclics has submitted a supplemental new drug application (sNDA) to the FDA based on the Sunnyvale, California-based firm's randomized, multicenter, open-label Phase III RESONATE PCYC-1112 study, a head-to-head comparison of single agent Imbruvica (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, who had received at least one prior therapy.

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