FDA panel backs Glaxo drug for rare sarcoma cancer

March 20, 2012 By MATTHEW PERRONE , AP Health Writer

(AP) -- A panel of cancer experts overwhelmingly backed the approval of a GlaxoSmithKline drug for a rare type of tumor, noting there are few other treatment options for patients.

The panel voted 11-2 that the benefits of the pill Votrient outweigh its side effects, even when considering that it did not significantly prolong life for patients with soft tissue sarcomas. The vote is not binding, but the agency usually follows its recommendations.

Glaxo's studies of Votrient showed the drug halted growth off the deadly tumors for three months on average. However, patients didn't ultimately live significantly longer than those taking . Chemotherapy has been the standard treatment for sarcomas for decades.

Most patients taking Votrient lived about 12.6 months after beginning treatment with the drug. That was only two months more than patients taking chemotherapy, and the FDA said the difference was not statistically significant.

Despite the lack of overall, doctors noted that a small group of patients lived four months or longer than the chemotherapy group.

"I feel the effect is marginal but there does appear to be a group of patients who have benefited from this for longer periods of time," said panel chair Dr. Wyndham Wilson of the .

Soft tissue sarcomas are a rare class of tumors that form in the fat, muscles and joints, often around the limbs and chest. An estimated 11,000 people in the U.S. were diagnosed in 2011 and 3,900 died from the disease, according to the National Cancer Institute.

Many approved by the FDA do not actually extend survival, but instead slow the growth of tumors or their spread to other parts of the body. In recent years, cancer experts have debated the significance of such results, particularly given the potentially dangerous side effects.

Side effects with Glaxo's pill included , and . But most panelists said chemotherapy can cause similar problems and there is a serious need for new drugs to treat sarcoma.

"There are no drugs approved by the FDA specifically for this indication and that's what drove my decision to vote yes," said Dr. Mikkael Sekeres of the Cleveland Clinic.

Soft tissue sarcoma is often curable if detected early. The patients studied by Glaxo had cancer that had spread to other parts of the body, despite chemotherapy. After that occurs life expectancy ranges between a year and a year and a half.

Shares of London-based GlaxoSmithKline PLC rose 9 cents to $45.58 in midday trading.

Explore further: FDA panel backs Pfizer drug for kidney cancer

shares

Related Stories

FDA panel backs Pfizer drug for kidney cancer

December 7, 2011
(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Recommended for you

Single blood test screens for eight cancer types

January 18, 2018
Johns Hopkins Kimmel Cancer Center researchers developed a single blood test that screens for eight common cancer types and helps identify the location of the cancer.

How cancer metastasis happens: Researchers reveal a key mechanism

January 18, 2018
Cancer metastasis, the migration of cells from a primary tumor to form distant tumors in the body, can be triggered by a chronic leakage of DNA within tumor cells, according to a team led by Weill Cornell Medicine and Memorial ...

Researchers find a way to 'starve' cancer

January 18, 2018
Researchers at Vanderbilt University Medical Center (VUMC) have demonstrated for the first time that it is possible to starve a tumor and stop its growth with a newly discovered small compound that blocks uptake of the vital ...

Modular gene enhancer promotes leukemia and regulates effectiveness of chemotherapy

January 18, 2018
Every day, billions of new blood cells are generated in the bone marrow. The gene Myc is known to play an important role in this process, and is also known to play a role in cancer. Scientists from the German Cancer Research ...

These foods may up your odds for colon cancer

January 18, 2018
(HealthDay)—Chowing down on red meat, white bread and sugar-laden drinks might increase your long-term risk of colon cancer, a new study suggests.

The pill lowers ovarian cancer risk, even for smokers

January 18, 2018
(HealthDay)—It's known that use of the birth control pill is tied to lower odds for ovarian cancer, but new research shows the benefit extends to smokers or women who are obese.

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.