March 20, 2012 / 6:47 PM / 6 years ago

FDA panel recommends Glaxo's Votrient for sarcoma

WASHINGTON (Reuters) - A U.S. Food and Drug Administration advisory panel recommended GlaxoSmithKline Plc’s (GSK.L) Votrient for treatment of advanced soft-tissue sarcoma, a relatively rare but aggressive form of cancer.

A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008. REUTERS/Toby Melville/Files

The FDA committee of outside experts voted 11-2 on Tuesday that the drug’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 FDA will now consider the committee’s recommendation in determining whether Votrient should be approved for treatment of soft-tissue sarcoma in the United States.

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.

Shares of GlaxoSmithKline were up 0.4 percent at 1435.5 pence in London trading after the panel made its recommendation.

Research showed the drug, known generically as pazopanib, has an overall safety profile for soft-tissue sarcoma that is similar to indications for renal cell carcinoma, for which Votrient received regulatory approval in 2009.

The National Cancer Institute estimates about 11,000 Americans were diagnosed with soft tissue sarcoma in 2011, and about 4,000 of them died from the disease.

Research showed that patients who received Votrient survived three months longer on average, without disease progression, compared with subjects who received a placebo.

But after a year’s time, the data showed no statistically significant improvement in overall survival rates.

Some members of the FDA panel questioned the drug’s effect on quality of life, noting that patients who received the drug experienced higher rates of some adverse events including vomiting, decreased appetite and fatigue.

Others described Votrient as only marginally effective but said its performance was favorable compared with other drugs available for a disease that is difficult to treat.

The company said the data showed only a limited view of worsening conditions among placebo patients, many of whom dropped out of the trial as their conditions deteriorated.

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

Analysts see the drug as a modest seller for the British drugmaker, with global sales expectations peaking around $500 million in 2016, according to forecasts from Thomson Reuters Pharma. The drug garnered global sales of about $60 million in 2010.

To convince British health regulators to pay for the drug, Glaxo proposed a clinical trial to compare it to a rival kidney cancer treatment from Pfizer Inc (PFE.N) called Sutent, agreeing to sell Votrient to Britain’s state-run health service for less money if it proved less effective.

Both Votrient and Sutent are protein kinase inhibitors, a relatively new class of targeted cancer treatment. They work by trying to block the vascular endothelial growth factor receptor to limit new blood vessels that can feed tumors.

Merck & Co Inc (MRK.N) is also developing its own treatment for soft tissue sarcoma via a license with tiny biotech company Threshold Pharmaceuticals Inc THLD.O.

Reporting by David Morgan; Editing by Lisa Von Ahn, Tim Dobbyn and Matthew Lewis

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