FDA expands ImmunityBio's Anktiva label to papillary-only bladder cancer
The approval adds adults with high-grade, BCG-unresponsive disease ahead of the Jan. 6, 2027 review target.
Theo Marchetti
The U.S. Food and Drug Administration expanded Anktiva's bladder-cancer indication on Wednesday, Oct. 14, to include adults with BCG-unresponsive, high-grade papillary-only tumours.
Evidence from 77 patients with carcinoma in situ supports the expanded label for ImmunityBio, Inc. NASDAQIBRX.
ImmunityBio shares traded at US$10.25 on NASDAQIBRX at 3:28 p.m. EDT on Wednesday, according to Google Finance.
The decision arrived ahead of the Jan. 6, 2027 target disclosed in the company's May 19 announcement of application acceptance. The FDA notice gives no separate launch date or sales forecast for the expanded indication.
ImmunityBio is a commercial-stage immunotherapy company. Anktiva, or nogapendekin alfa inbakicept-pmln, is administered into the bladder with Bacillus Calmette-Guérin, known as BCG. Its previous indication covered adults with BCG-unresponsive non-muscle invasive bladder cancer containing carcinoma in situ, with or without papillary tumours. The expansion adds high-grade papillary disease without carcinoma in situ.
The FDA Extrapolated Earlier Efficacy Evidence
The FDA said the two tumour types have different growth patterns but overlapping clinical and biological features. Both can recur or progress in the BCG-unresponsive setting, and they frequently coexist.
That overlap supported extending the earlier efficacy finding to the added patients. The approval notice does not present a new response rate for the papillary-only population.
The earlier evidence came from Cohort A of QUILT-3.032, identified as NCT03022825. The company describes QUILT-3.032 as a Phase 2/3 trial in its May 19 release.
The FDA's Oct. 14 account describes the earlier efficacy cohort as a single-arm, multicentre study, with complete response as the main outcome. Investigators assessed response using cystoscopy, urine cytology and biopsy.
The complete response rate was 62 per cent. The 95 per cent confidence interval ran from 51 to 73 per cent. Among patients who achieved a complete response, 58 per cent maintained it for at least 12 months.
The recommended induction course gives 400 micrograms of Anktiva with BCG weekly for six weeks. Maintenance can continue for a maximum treatment duration of 37 months.
The FDA lists urinary symptoms, infections and laboratory abnormalities among common adverse reactions. Its notice also carries a warning about delaying bladder-removal surgery:
"The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal," the FDA said in its approval notice.
Broader Eligibility Extends The Commercial Opportunity
ImmunityBio's May 19 release estimated that approximately 85 per cent of the 64,000 people diagnosed annually with non-muscle invasive bladder cancer in the United States present with papillary disease. That is a broader disease count than the approved high-grade, BCG-unresponsive group.
The expanded indication adds patients for whom Anktiva can be prescribed within its label. The annual diagnosis figure does not establish the number eligible for treatment or the additional revenue ImmunityBio could earn.
Johnson & Johnson NYSEJNJ announced Inlexzo's approval on Sept. 9, 2025 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumours. Its gemcitabine intravesical system delivers medication within the bladder.
Read more: Johnson & Johnson raises 2026 outlook after US$25.4B quarterly sales
The FDA approved Anktiva's expanded indication on Oct. 14, ahead of the January review target. The agency says updated prescribing information will be posted on Drugs@FDA, without specifying a posting date.
