Glaxo cancer drug Votrient gets approval

Friday, 4 May 2012 00:01 - - {{hitsCtrl.values.hits}}

WASHINGTON (Reuters): U.S. regulators gave the nod to GlaxoSmithKline Plc’s Votrient for soft-tissue sarcoma last week, 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 tumors 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 tumors and the approval of Votrient for this general class of tumors 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.