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 questions safety of Glaxo kidney cancer drug

shares

Related Stories

FDA questions safety of Glaxo kidney cancer drug

October 1, 2009

(AP) -- Federal regulators said Thursday an experimental kidney cancer drug from GlaxoSmithKline may cause liver problems, potentially outweighing its ability to slow the disease.

FDA panel backs Schering-Plough cancer drug

October 5, 2009

(AP) -- Federal health advisers voted 6-4 on Monday that the potential benefits of a Schering-Plough drug outweigh its toxic risks as a treatment for late-stage skin cancer.

Experts veto Avastin as a breast cancer treatment

July 20, 2010

(AP) -- A panel of cancer experts said Tuesday that the government should remove its endorsement of Roche's drug Avastin for breast cancer, after follow-up studies failed to show benefits for patients.

FDA reviews 2 new drugs to reduce prostate cancer

November 29, 2010

(AP) -- Health regulators said Monday that two drugs from GlaxoSmithKline and Merck reduce the risk of prostate cancer in men, though scientists questioned the drugs' overall benefit, since the tumors they prevent are usually ...

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

Excess weight linked to eight more cancer types

August 24, 2016

There's yet another reason to maintain a healthy weight as we age. An international team of researchers has identified eight additional types of cancer linked to excess weight and obesity: stomach, liver, gall bladder, pancreas, ...

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.