Stivarga approved for advanced colorectal cancer

September 27, 2012

(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.

Explore further: Zaltrap approved for advanced colorectal cancer

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


Related Stories

Zaltrap approved for advanced colorectal cancer

August 4, 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

June 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

August 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

July 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 and Drug Administration ...

Marqibo approved for ph- acute lymphoblastic leukemia

August 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 (ALL).

Kyprolis approved for multiple myeloma

July 20, 2012
(HealthDay) -- Kyprolis (carfilzomib) has been approved by the U.S. Food and Drug Administration to treat certain people with multiple myeloma who have already been given at least two prior therapies.

Recommended for you

Drug for spinal muscular atrophy prompts ethical dilemmas, bioethicists say

December 11, 2017
When the Food and Drug Administration approved the first drug for people with spinal muscular atrophy a year ago, clinicians finally had hope for improving the lives of patients with the rare debilitating muscular disease. ...

FDA's program to speed up drug approval shaved nearly a year off the process

December 7, 2017
Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. ...

Dangers of commonly prescribed painkillers highlighted in study

December 6, 2017
Commonly prescribed painkillers need to be given for shorter periods of time to reduce the risk of obesity and sleep deprivation, a new study has revealed.

Viagra goes generic: Pfizer to launch own little white pill

December 6, 2017
The little blue pill that's helped millions of men in the bedroom is turning white. Drugmaker Pfizer is launching its own cheaper generic version of Viagra rather than lose most sales when the impotence pill gets its first ...

Surgery-related opioid doses can drop dramatically without affecting patients' pain

December 6, 2017
Some surgeons might be able to prescribe a third of opioid painkiller pills that they currently give patients, and not affect their level of post-surgery pain control, a new study suggests.

Four-fold jump in deaths in opioid-driven hospitalizations

December 4, 2017
People who end up in the hospital due to an opioid-related condition are four times more likely to die now than they were in 2000, according to research led by Harvard Medical School and published in the December issue of ...

0 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.