CASODEX (bicalutamide), antiandrogen
ONCOLOGY - New indication and investigation
Opinions on drugs -
Posted on
Sep 28 2016
Reason for request
Renewal of inclusion
Substantial clinical benefit in metastatic prostate cancer, in combination with medical or surgical castration
Insufficient clinical benefit in the treatment of locally advanced prostate cancer, at high risk of disease progression, in treatment alone or as an adjuvant to radical prostatectomy or radiation therapy.
- CASODEX has Marketing Authorisation in the treatment of prostate cancer:
- metastatic, in combination with medical or surgical castration, at a dosage of 50 mg/day
- locally advanced prostate cancer, at high risk of disease progression, at a dosage of 150 mg/day, in treatment alone or as an adjuvant to radical prostatectomy or radiation therapy.
- Its therapeutic benefit remains substantial in metastatic prostate cancer, in combination with medical or surgical castration, at the dosage of 50 mg/day.
- With regard to current therapeutic methods, CASODEX has no role in the therapeutic strategy for locally advanced prostate cancer, at high risk of progression, at the dosage of 150 mg/day, either in treatment alone or as an adjuvant to radical prostatectomy or radiation therapy.
Clinical Benefit
Substantial |
- |
Insufficient |
Clinical Added Value
Not applicable |
- |
Therapeutic use
- |
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