FDA Breakthrough Status Sets Up Pharmacyclics’ Ibrutinib For Early Entry
This article was originally published in The Pink Sheet Daily
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 work in getting 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.