FDA accepts ImmunityBio sBLA for ANKTIVA plus BCG in papillary bladder cancer

ImmunityBio said the Food and Drug Administration accepted the company’s supplemental biologics license application for review for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The filing seeks a label expansion for Anktiva, which is currently approved for patients with BCG-unresponsive non-muscle invasive bladder cancer who have carcinoma in situ, and the FDA set a Prescription Drug User Fee Act target action date of Jan. 6, 2027.

The new BLA would expand Anktiva’s label to include its use in treating BCG-unresponsive non-muscle invasive bladder cancer cases with papillary disease, in addition to carcinoma in situ. Management said approximately 85% of the 64,000 people diagnosed with NMIBC in the U.S. each year present with papillary disease.

The company also released new comparison data indicating improved efficacy and safety of ANKTIVA plus BCG versus other approved bladder cancer therapies, presented at a major medical meeting. The new indirect comparison analyses suggested higher complete response rates, longer response duration, and fewer treatment-related adverse events versus specific alternatives.

The potential label expansion would keep ImmunityBio focused on a group of patients where treatment choices are relatively limited and where physicians already use BCG-based regimens. The company said many doctors have already been treating patients off-label with Anktiva because carcinoma in situ and papillary disease arise from the same cancer-inducing clone.

ImmunityBio said ANKTIVA plus BCG is positioned in the bladder cancer segment where patients often face limited options after BCG failure. The regulatory review process and reaction from the medical community to the new data will be key reference points over the coming quarters.