Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.


Related Content

Breakthrough Status May Not Be So Groundbreaking, Recent Reviews Indicate
FDA’s First Breakthrough Designations Continue Vertex Kalydeco’s Regulatory Successes
Ibrutinib Results Suggest Potential To Shake Up CLL Market
Industry Wants A Breakthrough Therapy, Even Without All The Standards


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts