Stivarga approved for advanced colorectal cancer

(HealthDay)—Stivarga (regorafenib) has been approved by the U.S. Food and Drug Administration to treat colorectal cancer that has spread despite prior treatment.

The drug belongs to a class called multi-kinase inhibitors, which are designed to block enzymes that promote , the FDA said in a news release.

Stivarga's safety and effectiveness were evaluated in a clinical study of 760 people who had been treated previously for advanced . People who took Stivarga lived an average of 6.4 months, compared with people given a placebo who lived an average of five months, the FDA said.

The most common side effects of the new drug included: weakness, fatigue, loss of appetite, diarrhea, mouth sores, weight loss, infection, high blood pressure and changes to the voice.

Stivarga was approved with a boxed label warning of the possibility of severe and fatal liver problems, the FDA said.

The drug is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J.

More information: The U.S. National Cancer Institute has more about colon and rectal cancer.

add to favorites email to friend print save as pdf

Related Stories

Zaltrap approved for advanced colorectal cancer

Aug 04, 2012

(HealthDay) -- Zaltrap (ziv-afilbercept) has been approved by the U.S. Food and Drug Administration in combination with a FOLFIRI chemotherapy regimen for adults with advanced metastatic (spreading) colorectal cancer, the ...

Perjeta approved for advanced breast cancer

Jun 11, 2012

(HealthDay) -- Perjeta (pertuzumab) has been approved by the U.S. Food and Drug Administration to treat people with HER2-positive late-stage breast cancer, the agency said in a news release.

Marqibo approved for rare leukemia

Aug 10, 2012

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with a rare form of blood and bone marrow cancer, Philadelphia chromosome negative ...

Afinitor approved for advanced breast cancer

Jul 23, 2012

(HealthDay) -- Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food ...

Marqibo approved for ph- acute lymphoblastic leukemia

Aug 10, 2012

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with Philadelphia chromosome negative acute lymphoblastic leukemia ...

Recommended for you

Powdered measles vaccine found safe in early clinical trials

17 hours ago

A measles vaccine made of fine dry powder and delivered with a puff of air triggered no adverse side effects in early human testing and it is likely effective, according to a paper to be published November 28 in the journal ...

Health care M&A leads global deal surge

Nov 23, 2014

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.