Also known as: TICE BCG, TICE® BCG
TICE BCG is an intravesical live attenuated Mycobacterium bovis (BCG) preparation used in bladder cancer management. It is indicated for treatment and prophylaxis of carcinoma in situ of the urinary bladder and for prophylaxis of selected Ta/T1 papillary tumors after transurethral resection. It is a marketed FDA biologic product and is not the TB-prevention BCG vaccine product.
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
