ImmunityBio, Inc. (IBRX) shares rose 1.12% to close at $9.91 on Wednesday, a gain of $0.11 after a volatile trading session. stock climbed a further 0.81% to $9.99 in after-hours trading as the company announced a major regulatory development: the U.S. Food and Drug Administration (FDA) expanded the approved use of ANKTIVA to cover patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) who have papillary-only tumors.

Key Points

• The FDA expanded ANKTIVA's indication, in combination with BCG therapy, to adults with BCG-unresponsive NMIBC and papillary-only tumors.
• IBRX gained 1.12% to $9.91 on Wednesday and added another 0.81% to $9.99 in after-hours trading.
• Data from Cohort A of the QUILT-3.032 trial showed a 62% complete response rate among 77 patients.
• NMIBC represents roughly 80% of U.S. bladder cancer diagnoses, with 85% to 90% of new cases presenting papillary disease.

FDA Widens ANKTIVA's Approved Patient Population

The FDA broadened ANKTIVA's indication for use in combination with Bacillus Calmette-Guérin (BCG) therapy, adding adults with papillary-only tumors to the treatment's approved patient population. As a result, ImmunityBio can now offer the combination to more patients whose bladder cancer no longer responds to BCG. That matters because BCG — a therapy delivered directly into the bladder that has anchored NMIBC treatment for decades — remains the standard first-line approach, making the loss of BCG response a critical turning point in patient care.

The decision builds on the FDA's initial approval of ANKTIVA in April 2024. That earlier authorization covered patients with BCG-unresponsive NMIBC involving carcinoma in situ (CIS), with or without papillary tumors, but it excluded patients who had papillary-only disease without CIS. The expanded indication marks the first FDA approval covering this specific group of bladder cancer patients.

With the updated label, ImmunityBio now holds approval for ANKTIVA plus BCG across both CIS and papillary-only disease. The broader label also increases the treatment's potential reach within the U.S. bladder cancer market.

Clinical Results Support the Expanded Use

In reaching its decision, the FDA reviewed existing scientific evidence supporting ANKTIVA's effectiveness in treating BCG-unresponsive bladder cancer. The evidence included results from Cohort A of ImmunityBio's QUILT-3.032 clinical trial, which evaluated ANKTIVA plus BCG in patients with CIS, with or without papillary tumors.

Among the 77 patients in the study, 62% achieved a complete response to treatment — meaning no detectable cancer remained on evaluation. In addition, 58% of responders maintained their response for at least 12 months, while 40% maintained it for at least 24 months, demonstrating sustained treatment benefit in a substantial share of patients. Durability of response carries particular weight in this setting, where treatment alternatives after BCG failure are limited.

The therapy also showed a manageable safety profile. Most reported adverse events involved bladder-related symptoms, with common reactions including painful urination, frequent urination, and blood in the urine, occurring mostly at mild or moderate levels. The prescribing information nevertheless warns that delaying bladder removal surgery can allow potentially fatal metastatic cancer to develop.

ImmunityBio Targets a Larger Bladder Cancer Market

Bladder cancer ranks among the most commonly diagnosed cancers in the United States, and non-muscle invasive disease accounts for approximately 80% of those diagnoses. An estimated 85% to 90% of newly diagnosed NMIBC patients present with papillary disease, figures that highlight the substantial patient population affected by the condition.

Patients with high-grade papillary tumors face significant risks once their cancer stops responding to BCG treatment. Recurrence and disease progression add to the challenge, particularly for those seeking alternatives to bladder removal surgery, which has historically been a standard recommendation once BCG loses effectiveness. The expanded approval therefore introduces another treatment option for eligible patients in this group.

ImmunityBio expects the broader indication to enlarge ANKTIVA's addressable U.S. market beyond its original CIS population. The company also aims to build on the commercial growth recorded since the treatment's initial approval in 2024, and the expanded label now gives it access to a patient population that previously fell outside the approved use. The latest FDA decision further strengthens ImmunityBio's position in bladder cancer immunotherapy and expands its potential commercial opportunities.

Source: Blockonomi