Burroughs Wellcome Co. said it was making a new anti-cancer drug available to critically ill lung cancer patients pending final U.S. approval of it for treatment of non-small cell lung cancer.
Lung cancer is expected to account for 153,000 deaths in the United States this year. About 75 percent to 85 percent of cases involve non-small cell cancer, company officials said.Burroughs Wellcome, the U.S. subsidiary of U.K.-based drug company Wellcome Plc, said it will make Navelbine available under an FDA approved program that allows investigational new drugs to be used to treat critically ill patients.
The company said it will be making the drug available to patients enrolled in the program free of charge.
Last December, the FDA's Oncologic Drugs Advisory Committee recommended that Navelbine be made commercially available to treat advanced non-small cell lung cancer and final FDA approval is still pending.
"The availability of Navelbine will be helpful for patients with non-small cell lung cancer," said Richard Gralla, M.D., director of the Ochsner Cancer Institute in New Orleans. "The data have shown a survival benefit with fewer side effects than related existing chemothereapy agents."
The drug is an intravenous therapy that is administered on an outpatient basis. It is being developed for use in North America by Burroughs Wellcome under a licensing agreement with Pierre Fabre Medicament in France, where the drug is being marketed for non-small cell lung cancer and advanced breast cancer.
Burroughs Wellcome said it also has asked the FDA for permission to market the drug in treating advanced breast cancer.