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ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data
Following multiple meetings with the FDA, ImmunityBio submitted additional information requested by the Agency to support its supplemental BLA (sBLA) for
About this update from Immunitybio, Inc.
[{"type":"text","content":"Following multiple meetings with the FDA, ImmunityBio submitted additional information requested by the Agency to support its supplemental BLA (sBLA) for papillary diseaseThe FDA reviewed the additional data provided by ImmunityBio in February 2026, and based on the Agency's feedback, the Company resubmitted the sBLAThe FDA has acknowledged receipt of the resubmitted filingThe sBLA aims to address the unmet need for patients with papillary-only NMIBC, supported by what is believed to be the longest duration of follow-up and bladder preservation data in this patient populationApproximately 60,000 people are diagnosed with NMIBC annually in the U.S., with approximately 70% presenting with papillary (Ta) disease1CULVER CITY, Calif., March 9, 2026 /PRNewswire/ -- ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.\n \n \n \n \n \n \n \nThe resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing. The long-term safety and efficacy results for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors have been published in The Journal of Urology. \"As far back as 2007, IL-15 was identified by leading scientific and medical organizations, including the NCI, NIH, FDA, AACR, and ASH, as the number one ranked immunotherapy molecule with the potential to cure cancer,\" said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. \"The mechanism of action of ANKTIVA's IL-15 superagon...