Abbott Laboratories said on Thursday it has received U.S. regulatory approval to make its experimental Prostate cancer drug Xinlay available to certain patients even though it is not yet approved.
The U.S. Food and Drug Administration has given Abbott permission to make Xinlay available in the United States to men with late-stage Prostate cancer who do not respond to hormone therapy under a program known as expanded access.
An Abbott spokeswoman said the company will distribute information about the drug to investigators in its clinical trials and to patient advocate groups. The drug will be made available later this summer.
It is currently being reviewed by the FDA. Abbott has said it expects a response from regulators in the fourth quarter of 2005. An FDA advisory hearing on Xinlay is set for September.
Abbott is seeking approval of Xinlay for men whose prostate cancer has spread to the bone and failed to respond to standard treatments. The company is conducting clinical trials to seek approval for use of the drug earlier in the disease.
Xinlay is an oral, once-a-day, non-chemotherapy cancer agent. It belongs to a class of compounds know as selective endothelin-A receptor antagonists, a protein thought to be involved in the spread of cancer cells.
About 230,000 U.S. men are diagnosed with prostate cancer and some 29,000 die from the disease each year.
Revision date: June 18, 2011
Last revised: by Jorge P. Ribeiro, MD