« Return to News | Clinical Intelligence

FDA approves Gleevec for rare gastrointestinal cancer

Thursday, February 2, 2012 08:32 AM

The FDA has granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST).

Gleevec, developed by Novartis, was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002. In 2008, Gleevec received a subsequent accelerated approval for adjuvant use for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST tumors, but who were at increased risk for a recurrence.

The Gleevec label is being updated to include clinical data from a large, randomized clinical study comparing patients receiving the pill for 12 months versus those receiving it for 36 months. Patients treated with Gleevec for 36 months had a significantly prolonged survival rate and non-recurrence rate, compared to those receiving it for 12 months. At 60 months, 92% of patients who had received 36 months of Gleevec were alive compared to 82% of patients who received 12 months of Gleevec.

“The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits,” said Richard Pazdur, M.D., director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research.

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.