On December 16, 1996, the Oncologic Drugs Advisory Committee reviewed the data supporting the use of TICE BCG for prophylaxis against recurrent papillary carcinoma of the urinary bladder. The committee was asked to consider five questions, proposed by the FDA, on the efficacy, safety, and infectious disease complications of using TICE BCG to treat papillary tumors of the bladder. Although the committee felt that the Nijmegen study did not provide evidence of the activity of TICE BCG for this indication, the committee did agree that the SWOG study 8795 data did support the use of TICE BCG in the prevention of TaTl tumors. The committee also responded positively about the overall safety and effectiveness of TICE BCG in the prophylactic therapy of tumors of the bladder. With respect to infectious disease concerns, the committee recommended that a more extensive discussion of infectious disease management, and especially the use of prophylactic isoniazid to treat inflammatory responses, should be included in the label.