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.

Related Stories

Zaltrap approved for advanced colorectal cancer

date 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

date 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

date 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

date 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

date 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

Emergency department opioid prescribing

date 4 hours ago

The Emergency Department (ED) is at the convergence of the opioid epidemic as emergency physicians (EPs) routinely care for patients with adverse effects from opioids, including overdoses and those battling addiction, as ...

Solid, heat-resistant vaccine to ease immunisation processes

date Apr 30, 2015

EU researchers have set out to substitute liquid and freeze-dried vaccines for new, solid state candidates. If successful, the research will enable the large scale production of new virosome-based vaccines with increased ...

Screening for bacteriuria in pregnant women: Benefit unclear

date Apr 30, 2015

Due to a lack of suitable studies, no conclusions can be drawn on the patient-relevant benefit or harm of screening for asymptomatic bacteriuria (ASB) in pregnant women. The benefit of antibiotic treatment of ASB following ...

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.