European Medicines Agency committee grants accelerated review for XBiotech’s Xilonix — 4 takeaways

The Committee for Medicinal Products for Human Use of the European Medicines Agency granted accelerated review for Xilonix by XBiotech, a biopharmaceutical company and developer based in Austin, Texas, according to Street Insider.

Advertisement

Here are four takeaways:

1. Xilonix is XBiotech’s first-in-class monoclonal antibody treatment for advanced colorectal cancer.

2. A decision on Xilonix’s approval could come as early as third quarter 2016.

3. XBiotech recently received approval of its marketing authorization application for Xilonix based on results of a phase III study, which showed a 76 percent relative improvement in response rate in patients treated with the antibody as compared to placebo.

4. In the United States, Xilonix has received Fast Track designation by the FDA for the treatment of advanced colorectal cancer.

More articles on GI & endoscopy:
4 GI physicians in the news — April 1, 2016
Gastroenterologist pay by US region: 9 notes
FDA approves rare liver disease treatment: 4 things to know

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Register to Attend Webinar

Building a High-Performance Cardiac PET Program: What Health Systems Should Consider

Thursday, July 30
12:00 PM - 1:00 PM CDT

Presenters: Rupa Sanghani, MD, FACC, FASNC, Rush University Medical CenterBrendon Loiselle, CDL Nuclear Technologies

Advertisement

Next Up in GI & Endoscopy

Advertisement

Comments are closed.