U.S. FDA approves Glaxo cancer drug Votrient

WASHINGTON Thu Apr 26, 2012 11:58pm BST

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WASHINGTON (Reuters) - U.S. regulators gave the nod to GlaxoSmithKline Plc's (GSK.L) Votrient for soft-tissue sarcoma on Thursday, the first new drug in decades to treat patients with this type of cancer.

The U.S. Food and Drug Administration approved the pill for people with soft-tissue sarcoma who have already received chemotherapy, following a positive advisory panel vote last month.

The drug treats more than 20 subtypes of soft-tissue sarcoma, a group of rare but aggressive cancers that usually begin in the muscles, fat or other tissues.

This type of cancer afflicted about 11,000 Americans last year, and about 4,000 died from the disease, according to the National Cancer Institute.

Votrient, which is already approved for advanced kidney cancer, works by interfering with the growth of new blood vessels that tumours need to survive.

Dr. Richard Pazdur, head of the FDA's office of oncology products, said it is especially hard to develop new drugs to treat sarcoma because there are so few patients, and so many subtypes, of the cancer.

"Soft tissue sarcomas are a diverse group of tumours and the approval of Votrient for this general class of tumours is the first in decades," he said.

The FDA gave Votrient orphan status, meaning it treats a condition that affects fewer than 200,000 people in the United States. That means Glaxo gets seven years of marketing exclusivity now that the drug is approved.

The company tested the drug in a single clinical trial of 369 patients who had already gotten chemotherapy. Votrient improved the amount of time without cancer progressing by three months compared to a placebo.

At an advisory committee meeting in March, outside experts to the FDA said they were willing to consider treatments shown in clinical trials to be only marginally effective because sarcoma is so aggressive and alternative treatments so few.

Votrient carries a boxed warning, the most serious kind, about its potential link to liver damage, which can be fatal.

Glaxo shares closed up 0.5 percent earlier in the day.

(Reporting by Anna Yukhananov in Washington and Vidya Loganathan in Bangalore; Editing by Bernard Orr)

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