AstraZeneca Responds To FDA Action On Supplemental New Drug
Application For CASODEX 150mg
WILMINGTON, Del., June 20 /PRNewswire-FirstCall/ -- AstraZeneca Pharmaceuticals (NYSE: AZN - News) today
announced that the FDA has issued a "not approvable letter" to the company for its supplemental new drug application
(sNDA) for CASODEX (bicalutamide) 150mg for the treatment of non-metastatic prostate cancer. This action does not
impact the current use and approval of CASODEX (bicalutamide) 50mg formulation for advanced prostate cancer
treatment.
"Having failed to reach consensus with the FDA as to the most appropriate use of this potential new therapy, we are
reviewing a number of options including requesting an advisory committee meeting," says Dr. Gerard T. Kennealey, Vice
President of Oncology Research at AstraZeneca. "In addition, the FDA has suggested that we request a public hearing to
review the data and discuss the findings in an open forum. AstraZeneca firmly believes that CASODEX 150 mg addresses
a current unmet medical need, and we will continue to work with the FDA to bring this treatment option to patients."
CASODEX 150mg is currently approved for the treatment of early or locally advanced prostate cancer in 50 countries
around the world including the UK.
Men who have undergone standard treatment for prostate cancer, including radiation or surgery, have disease recurrence
rates of 30% to 40% or more at 10 years. The sNDA submission was based on the Early Prostate Cancer (EPC)
program which was undertaken to investigate if the addition of CASODEX 150mg to standard treatment, or as immediate
therapy for men who select watchful waiting, would reduce the risk of disease recurrence. It was designed on the same
premise as the adjuvant trials of tamoxifen for breast cancer. The EPC program is the largest prostate cancer treatment
study to date, including over 8,000 patients from 23 countries around the world.
Approved by the FDA in October of 1995, CASODEX 50mg is indicated for use in combination therapy with a
luteinizing hormone-releasing hormone analogue (LHRH-A), for the treatment of Stage D2 metastatic prostate cancer.
CASODEX 50mg is the best selling anti-androgen in the world. Serum transaminase levels should be measured prior to
starting treatment with CASODEX, at regular intervals for the first four months of treatment, and periodically thereafter.
The most commonly reported adverse events, regardless of causality, for CASODEX 50 mg plus an LHRH-A, were hot
flashes, pain, back pain, asthenia, constipation, pelvic pain, infection, nausea, dyspnea, peripheral edema, diarrhea,
hematuria, and nocturia...... |
