FDA expands Anktiva plus BCG label to papillary-only bladder cancer

The FDA on 14 October 2026 expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln) with BCG to adults with BCG-unresponsive, high-grade papillary-only non-muscle-invasive bladder cancer. ImmunityBio said it is the first FDA approval to include that papillary-only group.

The expanded label reads:

ANKTIVA, in combination with Bacillus Calmette-Guerin (BCG), is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer.

The previous approval, in April 2024, covered patients with carcinoma in situ, with or without papillary tumors. The new label text is broader than the group the FDA highlighted: it covers BCG-unresponsive non-muscle invasive bladder cancer without naming a subtype, while the agency said the expanded use is for high-grade papillary-only disease.

Papillary disease accounts for an estimated 85% to 90% of NMIBC diagnoses, ImmunityBio said, citing published research. NMIBC is about 80% of all US bladder cancer diagnoses. For patients whose cancer returned after BCG, the main alternative has often been radical cystectomy, the surgical removal of the bladder.

The evidence

The FDA based the expansion on extrapolation from Cohort A of the QUILT-3.032 trial, which enrolled 77 patients with CIS, with or without papillary tumors, rather than on a new efficacy trial in papillary-only disease. The application also included longer follow-up from the trial's papillary-only Cohort B. Sixty-two percent achieved a complete response, with a 95% confidence interval of 51% to 73%. Among responders, 58% held the response for at least 12 months and 40% for at least 24 months.

The agency concluded that CIS and high-grade papillary tumors often coexist, can be difficult to distinguish under a microscope and carry a high risk of recurrence and progression after BCG fails. It said those similarities allowed it to extend the CIS results to papillary-only disease.

For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments.

R. Angelo de Claro, director of the FDA's Oncology Center of Excellence

There is papillary-only data, but it is single-arm. Cohort B of QUILT-3.032 enrolled 80 patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC. Disease-free survival was 58.2% at 12 months, with a 95% confidence interval of 46.6% to 68.2%, then 52.1% at 24 months and 38.2% at 36 months, Urology Times reported. Cystectomy avoidance was 92.2% at 12 months and 81.8% at 36 months. With no comparator, the cohort cannot show how the drug performs against another treatment.

The National Comprehensive Cancer Network gave intravesical Anktiva plus BCG a Category 2A recommendation for papillary-only disease in March 2026, before the FDA action, OncLive reported.

ImmunityBio said on 19 May 2026 that the FDA had accepted the supplemental application for review, with a PDUFA date of 6 January 2027. The agency said the review would focus on whether extrapolating the CIS results to papillary-only disease was justified.

Dosing and safety

Anktiva is an interleukin-15 receptor agonist given into the bladder through a catheter with BCG: 400 mcg once a week for six weeks, with a second induction course if residual CIS or high-grade Ta tumors remain at month 3.

Maintenance is three weekly instillations at months 4, 7, 10, 13 and 19, with further courses at months 25, 31 and 37 for patients without high-grade disease. Treatment can run up to 37 months.

Treatment stops if disease persists after a second induction course, if the cancer returns or progresses, or if side effects become unacceptable. The most common adverse reactions, in at least 15% of patients, included dysuria, hematuria, urinary frequency and urgency, urinary tract infection, increased creatinine and potassium, musculoskeletal pain, chills and pyrexia. ImmunityBio said most were grade 1 or 2 and consistent with BCG alone.

The prescribing information warns that delaying cystectomy can lead to metastatic bladder cancer, which can be lethal.

What happens next

The FDA said it is working to finalize draft guidance titled Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment. The guidance is intended to include discussion of using evidence from CIS studies to support approval of treatments for BCG-unresponsive, high-grade papillary-only NMIBC. ImmunityBio said the broader label significantly increases its US addressable patient population beyond the CIS indication.