ORGANON TICE BCG VACCINE RECOMMENDED FOR RECURRENT PAPILLARY BLADDER CARCINOMA BASED ON ONE TRIAL; INFECTIOUS DISEASE CONTACTS TO BE LISTED IN LABELING
Executive Summary
A single pivotal trial of Organon's Tice Bacillus-Calmette Guerin vaccine for intravesical installation against recurrent papillary carcinoma of the bladder is sufficient to support approval, FDA's Oncologic Drugs Advisory Committee agreed Dec. 16.