AstraZeneca PLC
21 June 2002
ASTRAZENECA RESPONDS TO FDA ACTION ON SUPPLEMENTAL NEW DRUG APPLICATION FOR
CASODEX 150MG FOR EARLY PROSTATE CANCER
AstraZeneca today announced that the US Food and Drug Administration (FDA) has
issued a non-approvable letter for its supplemental new drug application (sNDA)
for 'Casodex' (bicalutamide)150mg for the treatment of early prostate cancer.
The FDA's decision does not impact on the current use and approval of 'Casodex'
50mg formulation for advanced prostate cancer treatment.
Casodex 150mg is currently being evaluated in the largest ever treatment study
in prostate cancer - the Early Prostate Cancer (EPC) programme. AstraZeneca
strongly believes that the first results from the EPC programme show that
Casodex 150mg provides important benefits for patients with the early stages of
prostate cancer. The company wants to fully review its options with the FDA to
find the best way forward, including possibly requesting an advisory committee
meeting. In addition, the FDA has suggested that AstraZeneca requests a public
hearing to review the data and discuss the findings in an open forum.
'Casodex' 150mg is currently approved for the treatment of early or locally
advanced prostate cancer in 50 countries around the world including the UK,
Italy, Austria and Mexico.
One third or more of men that undergo standard care (radical prostatectomy,
radiotherapy or watchful waiting) for early prostate cancer have their disease
return. The sNDA submission was based on the first results of the Early
Prostate Cancer (EPC) programme, which showed that adding 'Casodex' 150mg to
standard care reduces the risk of tumour progression by almost a half and
reduces the incidence of bone metastases by a third in patients with localised
or locally advanced (early) prostate cancer, compared with standard care alone.
AstraZeneca and the FDA clearly had a difference of opinion on the
interpretation of the data and how it applies to patients. The EPC programme
was designed on the same premise as the adjuvant trials of tamoxifen for breast
cancer. The EPC programme is the largest prostate cancer treatment study to
date including over 8,000 patients from 23 countries around the world.
AstraZeneca remains committed to the Casodex 150 mg EPC programme and continues
to seek approval for this indication in countries worldwide.
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of ethical (prescription)
pharmaceuticals and the supply of healthcare services. It is one of the top
five pharmaceutical companies in the world with healthcare sales of $16.4
billion and leading positions in sales of gastrointestinal, oncology,
anaesthesia (including pain management), cardiovascular, central nervous system
(CNS) and respiratory products.
'Casodex' is a trademark of the AstraZeneca group of companies
Date: 21st June 2002
NOTES: Information about AstraZeneca and full prescribing information for all
AstraZeneca products are available at www.astrazeneca.com
For further information, please contact:
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
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Jonathan Hunt, Tel: +44 (0) 207 304 5087
- Ends -
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