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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.

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