« Return to News | Drug Sponsors

Pfizer files NDA for new oncology drug

Wednesday, May 18, 2011 12:07 PM

Pfizer has filed a new drug application for its oncology drug crizotinib with regulators in the U.S. and Japan.

Crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, has been accepted for filing and granted priority review status by the FDA. It has also been submitted to the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC).

Results from an expansion cohort of a phase I/II trial showed that at eight weeks, 87% of patients given crizotinib had responded to treatment—57% of those experiencing tumor shrinkage. About 3%-5% of NSCLC patients have tumors that are positive for the ALK- fusion gene.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.