AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA
22 September 2008 - 7:23PM
PR Newswire (US)
WILMINGTON, Del., Sept. 22 /PRNewswire-FirstCall/ -- AstraZeneca
today announced that the United States Food and Drug Administration
(FDA) has granted an additional six-month period of exclusivity to
market CASODEX(R) (bicalutamide) for its licensed advanced prostate
cancer indication until April 1, 2009. AstraZeneca has been working
with the FDA in the investigation of the safety and effectiveness
of CASODEX in a pediatric setting but will not be seeking an
indication in this population. CASODEX is currently approved in the
US at a dose of 50 mg daily tablet for use in combination with a
luteinizing hormone-releasing hormone analog (LHRH-A) for the
treatment of advanced prostate cancer (metastatic Stage D2).
AstraZeneca has a well-established prostate cancer portfolio
including hormonal treatments CASODEX, launched in 1995, and
ZOLADEX(R) (goserelin acetate implant), launched in 1989. Three
Phase III clinical research trials (ENTHUSE program) are currently
underway to evaluate the safety and effectiveness of an
investigational compound, ZD4054, in non-metastatic and metastatic
hormone-resistant prostate cancer. About Prostate Cancer Over
186,000 men will be diagnosed with prostate cancer in the U.S. in
2008, making it the most frequently diagnosed cancer in men.(1)
After lung cancer, prostate cancer is the second leading cause of
cancer death in men, with an estimated 28,660 deaths in 2008.(2)
One in six men will develop prostate cancer in his lifetime. About
CASODEX(R) (bicalutamide) Tablets CASODEX at a dose of 50 mg daily
is a prescription medication approved for use in combination with
an injection of a luteinizing hormone-releasing hormone analog
(LHRH-A) for treatment of advanced prostate cancer (metastatic
Stage D2). CASODEX at a dose of 150 mg daily is not approved for
use alone or with other treatments. See full Prescribing
Information under the section on "CLINICAL PHARMACOLOGY-Clinical
Studies-Safety Data from Clinical Studies using CASODEX 150 mg" for
additional important safety information regarding CASODEX 150 mg.
Important Safety Information about CASODEX There have been reports
of liver function problems during treatment with CASODEX.
Therefore, your doctor will monitor your liver function with a
blood test before you start treatment with CASODEX, at regular
intervals during the first 4 months of treatment, and at regular
times after that. The most common side effects that occurred during
treatment with CASODEX plus an injection of an LHRH-A were hot
flashes (53%), pain (21% to 35%, including pelvic, back, and
general), weakness (22%), and constipation (22%). Other side
effects (reported in 12% to 18% of patients) were urination at
night, blood in urine, diarrhea, swelling, shortness of breath,
nausea, and infection. For more information about CASODEX,
including full Prescribing Information please visit
http://www.prostateinfo.com/. About ZOLADEX(R) (goserelin acetate
implant) ZOLADEX 3.6 mg depot and 10.8 mg depot are prescription
medications approved for use in combination with flutamide (an
antiandrogen) plus radiotherapy for locally advanced prostate
cancer. Treatment with the combination should start 8 weeks prior
to starting and continue during radiation therapy. ZOLADEX 3.6 mg
depot and 10.8 mg depot are also approved to use alone for patients
with advanced prostate cancer. ZOLADEX may help reduce the size of
the cancer and reduce symptoms (palliative treatment). Important
Safety Information about ZOLADEX ZOLADEX, like other luteinizing
hormone-releasing hormone analogs (LHRH-As), may cause an initial
rise in testosterone. When used alone, there may be a temporary
worsening of prostate cancer symptoms at the start of therapy.
Common side effects that occurred during treatment with ZOLADEX
(goserelin acetate implant) plus flutamide and radiation therapy or
ZOLADEX alone included hot flashes, decrease in sexual desire
and/or ability to have erections, diarrhea, pain (general, pelvic,
and bone), lower urinary tract symptoms, fatigue, nausea, breast
growth, swelling, rash, upper respiratory infection, and sweating.
For more information about ZOLADEX, including full Prescribing
Information for ZOLADEX 3.6 mg Depot and ZOLADEX 10.8 mg Depot
visit http://www.prostateinfo.com/. About AstraZeneca AstraZeneca
is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and supplier for healthcare services.
AstraZeneca is one of the world's leading pharmaceutical companies
with healthcare sales of $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infectious disease medicines. In the United States,
AstraZeneca is a $13.35 billion dollar healthcare business with
12,200 employees committed to improving people's lives. AstraZeneca
is listed in the Dow Jones Sustainability Index (Global) as well as
the FTSE4Good Index. For more information visit:
http://www.astrazeneca-us.com/. (1) Cancer Facts & Figures
2008. American Cancer Society publication.
http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts_and_Figures_2008
.asp. Accessed July 8, 2008. (2) Cancer Facts & Figures 2008.
American Cancer Society publication.
http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts_and_Figures_2008
.asp. Accessed July 8, 2008. (Due to the length of these URLs,
please copy and paste into your browser.) DATASOURCE: AstraZeneca
CONTACT: Laurie Casaday of AstraZeneca LP, +1-302-885-2699, Web
site: http://www.astrazeneca-us.com/ http://www.prostateinfo.com/
Company News On-Call: http://www.prnewswire.com/comp/985887.html
Copyright