Abbott says access to prostate cancer drug widened

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.

RELATED STORIES:
Testosterone Replacement in Older Men Does Not Increase Risk of Prostate Cancer   Study shows further benefits of noscapine for prostate cancer   Prostate Cancer Surgeons “Feel” With Their Eyes   Painkillers may cut prostate cancer risk a little   Delaying therapy OK for low-risk prostate cancer   Older men may not need prostate cancer screening   Predictive model of prostate cancer risk   Men Who Take Aspirin Have Significantly Lower PSA Levels   Prostate Cancer Patients Undergoing Hormone Therapy May Experience Cognitive Effects   Study finds acceptable levels of anxiety among men living with early, untreated prostate cancer   Scientists see progress in prostate cancer tests   Online tool supports more dialogue on prostate cancer risk   Most prostate cancer patients opt for surgery   U.S. Trial Shows No Early Mortality Benefit from Annual Prostate Cancer Screening   Family counseling improves lives of patients and spouses coping with prostate cancer   Younger men with advanced prostate cancer have shorter survival times   Predicting the Return of Prostate Cancer: New Study Betters the Odds of Success   Prostate cancer treatment choices vary based on type of specialist consulted   Cholesterol and cancer: Answers and some new questions   Folic Acid Supplements Linked To Higher Risk Of Prostate Cancer   Drug Shows Activity in Men with Advanced Prostate Cancer   For men with prostate cancer, treatment information fails to address fears

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]