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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