FDA Breakthrough Status Sets Up Pharmacyclics’ Ibrutinib For Early Entry
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pharmacyclics/J&J’s BTK inhibitor ibrutinib already looked extremely well-positioned for B-cell cancers, but how qualifying for FDA’s nascent breakthrough pathway will get the drug to market faster is still unclear. Breakthrough status is limited to drugs that meet a very high bar, so the designation alone further boosts the candidate’s promising profile.
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