FDA approves new treatment for advanced colorectal cancer

Friday, September 28, 2012 12:19 PM

The FDA has approved Bayer’s and Onyx Pharmaceuticals’ Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body.

Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.

Stivarga is being approved one month ahead of the product's prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application.

The safety and effectiveness of Stivarga were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or placebo in addition to best supportive care (BSC), which includes treatments to help manage side effects and symptoms of cancer. Patients received treatment until their cancers progressed or side effects became unacceptable.

Study results showed patients treated with Stivarga plus BSC lived a median of 6.4 months compared to a median of 5.0 months in patients treated with placebo plus BSC. Results also showed patients treated with Stivarga plus BSC experienced a delay in tumor growth (progression-free survival) for a median of 2.0 months compared to a median of 1.7 months in patients receiving placebo plus BSC.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs