GlaxoSmithKline Plc won U.S. clearance to expand marketing of its 2-year-old kidney-cancer pill Votrient for rare malignancies known as soft-tissue sarcomas.
The Food and Drug Administration approved the drug for patients with tumors in tissues such as muscle, fat or blood vessels who have had chemotherapy, the agency said today in a statement.
Glaxo, based in London, won FDA approval in 2009 for Votrient, also known as pazopanib, as a treatment for advanced renal-cell carcinoma. Pfizer Inc.’s Sutent and Nexavar from Bayer AG and Onyx Pharmaceuticals Inc. are among competing kidney cancer drugs. Glaxo, the U.K.’s biggest drugmaker, may earn almost 148 million pounds ($231 million) from Votrient this year, according to the average estimate of five analysts surveyed by Bloomberg.
“Soft tissue sarcomas are a diverse group of tumors and approval of Votrient for this general class of tumors is the first in decades,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in the statement.
While there are more than 50 types of soft-tissue sarcomas, they represent about 1 percent of U.S. cancer cases, according to Memorial Sloan-Kettering Cancer Center in New York. About 20 percent of people diagnosed with the tumors are younger than 35, according to the Sarcoma Alliance, a nonprofit patient advocacy group in Mill Valley, California.
Merck & Co. and Ariad Pharmaceuticals Inc. are seeking FDA approval for an experimental soft-tissue sarcoma drug called ridaforolimus that may compete with Votrient. Whitehouse Station, New Jersey-based Merck is the second-biggest U.S. drugmaker after Pfizer.
Sanofi, France’s biggest drugmaker, and Johnson & Johnson, the world’s largest health-products company, are among others developing sarcoma treatments, according to Bloomberg Industries.