AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA

Tuesday, September 23, 2008 General News
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WILMINGTON, Del., Sept. 22 AstraZeneca todayannounced that the United States Food and Drug Administration (FDA) hasgranted an additional six-month period of exclusivity to market CASODEX(R)(bicalutamide) for its licensed advanced prostate cancer indication untilApril 1, 2009. AstraZeneca has been working with the FDA in the investigationof the safety and effectiveness of CASODEX in a pediatric setting but will notbe seeking an indication in this population.

CASODEX is currently approved in the US at a dose of 50 mg daily tablet foruse 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 includinghormonal treatments CASODEX, launched in 1995, and ZOLADEX(R) (goserelinacetate implant), launched in 1989. Three Phase III clinical research trials(ENTHUSE program) are currently underway to evaluate the safety andeffectiveness of an investigational compound, ZD4054, in non-metastatic andmetastatic hormone-resistant prostate cancer.

About Prostate Cancer

Over 186,000 men will be diagnosed with prostate cancer in the U.S. in2008, making it the most frequently diagnosed cancer in men.(1) After lungcancer, 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 developprostate cancer in his lifetime.

About CASODEX(R) (bicalutamide) Tablets

CASODEX at a dose of 50 mg daily is a prescription medication approved foruse in combination with an injection of a luteinizing hormone-releasinghormone analog (LHRH-A) for treatment of advanced prostate cancer (metastaticStage D2).

CASODEX at a dose of 150 mg daily is not approved for use alone or withother treatments. See full Prescribing Information under the section on"CLINICAL PHARMACOLOGY-Clinical Studies-Safety Data from Clinical Studiesusing CASODEX 150 mg" for additional important safety information regardingCASODEX 150 mg.

Important Safety Information about CASODEX

There have been reports of liver function problems during treatment withCASODEX. Therefore, your doctor will monitor your liver function with a bloodtest before you start treatment with CASODEX, at regular intervals during thefirst 4 months of treatment, and at regular times after that.

The most common side effects that occurred during treatment with CASODEXplus 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 atnight, blood in urine, diarrhea, swelling, shortness of breath, nausea, andinfection.

For more information about CASODEX, including full Prescribing Informationplease visit

About ZOLADEX(R) (goserelin acetate implant)

ZOLADEX 3.6 mg depot and 10.8 mg depot are prescription medicationsapproved for use in combination with flutamide (an antiandrogen) plusradiotherapy for locally advanced prostate cancer. Treatment with thecombination should start 8 weeks prior to starting and continue duringradiation therapy.

ZOLADEX 3.6 mg depot and 10.8 mg depot are also approved to use alone forpatients with advanced prostate cancer. ZOLADEX may help reduce the size ofthe 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, theremay be a temporary worsening of prostate cancer symptoms at the start oftherapy.

Common side effects that occurred during treatment with ZOLADEX (goserelinacetate implant) plus flutamide and radiation therapy or ZOLADE

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