ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027
Supplemental BLA seeks to expand the ANKTIVA label to include patients with BCG-unresponsive NMIBC with papillary disease
FDA noted in its filing communication that the supplemental BLA accepted for review was based on the additional scientific data ImmunityBio provided at the Agency’s request, detailing the overlapping features of papillary and CIS disease to determine adequate justification to allow for the expansion of the already approved indication of ANKTIVA with BCG to include the treatment of patients with BCG unresponsive NMIBC with papillary tumors
During the FDA workshop held on May 18, 2026, panelists stated that CIS and papillary disease arise from the same cancer inducing clone, is therefore the same disease biologically, and that the clinical treatment decision made by the panelists when papillary disease alone is identified, is to treat the patient off-label with an already FDA approved therapy for CIS and papillary disease
This analysis of the experts at the FDA workshop was consistent with the recent decision (March 2026) by the NCCN panel of experts to designate the treatment of BCG-unresponsive non-muscle invasive bladder cancer papillary disease as a Category 2A guideline for practicing urologists treating such patients with papillary disease alone.
