Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



Breakthrough Status May Not Be So Groundbreaking, Recent Reviews Indicate

A look at some of FDA’s novel drug approvals analyzed in Pharmaceutical Approvals Monthly’s 2012 series of drug review profiles suggests that the agency has already ushered through several approvals that could be models for the new “breakthrough” designation created by the FDA Safety and Innovation Act.

FDA’s First Breakthrough Designations Continue Vertex Kalydeco’s Regulatory Successes

Label expansion efforts for Vertex’s cystic fibrosis therapy will be claims taken through FDA’s new review pathway; the initial product could reach more patients more quickly and serve as a guide to how the agency will handle drugs earmarked for streamlined development and approval.

Ibrutinib Results Suggest Potential To Shake Up CLL Market

Momentum builds for Pharmacyclics/J&J’s ibrutinib with release of new data at the American Society of Hematology meeting, suggesting the drug has a shot at accelerated approval in sub-populations with high unmet need and potential in a range of B-cell cancers. Profiles of competitors from Gilead and Infinity/Takeda also came into greater focus at ASH.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM017175

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel