Bonefos
clodronate
Treatment forBonefos Accepted for Filing and Granted Priority Review by FDA
MONTVILLE, N.J., September 9, 2004 -- Berlex Laboratories, a U.S. affiliate of Schering AG, Germany announced today that Bonefos (clodronate) has been accepted for filing and designated for priority review by the U.S. Food and Drug Administration (FDA). Berlex is seeking approval for the use of Bonefos as an adjuvant oral treatment for reducing the occurrence of bone metastases in stage II/III breast cancer patients.
"We are extremely excited with the FDA's decision to accept Bonefos for priority review", said Reinhard von Roemeling, MD, Vice President of Clinical Development, Oncology. "This is an important milestone and recognizes the significant unmet medical need facing women with breast cancer." The FDA gives priority designation to products that are considered to be a potential significant therapeutic advancement over existing therapies and that address an unmet medical need. The priority review designation provides for a six month review from the date of filing.
Additional information
About Breast Cancer A National Cancer Institute (NCI) report
estimates that about 1 in 8 women in the United States
(approximately 13 percent) will develop breast cancer during her
lifetime. The American Cancer Society estimates that each year
nearly 175,000 American women will be diagnosed with breast cancer.
43,300 women will die from breast cancer this year. Breast cancer
is the leading cause of death among women between 40 and 55 years
of age and is the second overall cause of death among women
(exceeded only by lung cancer). Fortunately, the mortality rate
from breast cancer has decreased in recent years with an increased
emphasis on early detection and more effective treatments.
Bone metastases are one of the most common forms of recurrence in breast cancer following standard adjuvant therapy. It is estimated that approximately up to 70 percent of women whose breast cancer metastasized will develop at least one skeletal lesion during the course of the disease. Epidemiological data show that once patients with breast cancer develop bone metastases their life expectancy is approximately 21 months.
About Bonefos (clodronate)
Clodronate is a bisphosphonate, and a potent inhibitor of
osteoclast- mediated bone resorption. Consequently, clodronate is
able to inhibit cancer cell stimulated osteolytic activity, thereby
helping the structure of the bone. Bonefos is approved in 79
countries for the treatment of tumor- induced osteolysis and
hypercalcemia. So far, there is approximately 260,000 patient years
of experience with Bonefos as a marketed product.
Adverse Effects
Diarrhea may occur in approximately 10% of patients, but this
reaction is usually mild, and did not lead to early drug
discontinuation as compared to placebo control in a large,
randomized, double-blind clinical trial.
About Berlex
Committed to developing novel diagnostics and therapeutics that
address unmet medical needs, Berlex develops and markets diagnostic
imaging agents, treatments in the areas of female healthcare,
oncology and dermatology, as well as specialized therapeutics for
life-threatening and disabling diseases in the fields of the
central nervous and cardiovascular systems and gastroenterology.
Berlex has business operations in New Jersey, California and
Washington.
For more information, please visit www.berlex.com.
Related Articles:
Further Trial Data Awaited for Bonefos in the U.S. - May 11, 2005
Berlex Receives Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer - January 7, 2005
New Drug Applications Archive
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
