March 20, 2012 / 4:02 PM / 5 years ago

FDA panel splits recommendations on sarcoma drugs

WASHINGTON (Reuters) - A U.S. Food and Drug Administration advisory panel recommended GlaxoSmithKline Plc's Votrient for soft-tissue sarcoma on Tuesday, but did not recommend a treatment for the same malady developed jointly by Merck & Co Inc and Ariad Pharmaceuticals Inc.

The FDA committee of outside experts voted 11-2 in finding that Votrient's ability to improve short-term survival without worsening symptoms in patients who receive chemotherapy outweighed adverse risks and a lack of evidence that it can extend overall survival.

The same panel voted 13-1 not to recommend Merck's drug Taltorvic for soft-tissue and bone sarcoma after reviewing data that associated the drug with serious adverse effects but produced only small improvements in patients who had completed at least four cycles of chemotherapy.

The regulatory agency will now consider the committee's recommendations in reaching separate decisions on whether each drug should be approved for sale in the United States for soft-tissue sarcoma.

An FDA official said the agency could give Votrient accelerated approval to ensure further study of the drug's efficacy, including questions about patient quality of life, on patients with soft-tissue sarcoma. The drug is already approved for renal cell carcinoma.

Shares of GlaxoSmithKline closed 0.2 percent higher at 1433.5 pence in London trading after the panel made its recommendation for Votrient.

The committee's vote on Taltorvic occurred as share trading closed in New York, with Merck down 13 cents at $37.76 and Ariad shares off 18 cents at $15.05.

Soft-tissue sarcoma is a rare but aggressive form of cancer that afflicted about 11,000 Americans last year, 4,000 of whom died from the disease, according to the National Cancer Institute.

FDA committee members said they were willing to consider treatments shown in clinical trials to be only marginally effective because the disease is so aggressive and alternative treatments so few.

That was part of the rationale behind the panel's recommendation for Glaxo's Votrient, which was shown to allow patients to survive three months longer on average, without disease progression, compared with subjects who received a placebo, but showed no significant improvement in overall survival rates.

Committee members were less charitable toward Taltorvic, which is also known by the chemical name ridoforolimus, which was shown to improve survival without disease progression by only a matter of weeks but with adverse impacts including death and hospitalization.

Panelists noted findings that four out of five patients who participated in the Taltorvic study experienced adverse effects severe enough for the treatment to be scaled back or discontinued.

"How is it clinically meaningful to expose patients, for far longer than they should need to be, to a toxic drug for the benefit of three weeks?" asked the panel's chairman, Dr. Wyndham Wilson of the National Cancer Institute.

Adverse events from Talrovic included pneumonitis, renal failure, pneumonia and other infections as well as hyperglycemia.

Matthew Alsante, executive director of the Sarcoma Foundation of America, implored panel members to approve both drugs, saying sarcoma patients have few alternative treatments for fending off worsening symptoms and death.

Reporting by David Morgan; Editing by Gary Hill

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