TLDR
- IBRX climbs 1.12% to $9.91 as FDA expands ANKTIVA’s bladder cancer approval.
- FDA clears ANKTIVA plus BCG for papillary-only bladder cancer patients in the U.S.
- ANKTIVA’s wider label opens treatment to more patients with BCG-resistant tumors.
- Clinical trial finds 62% complete response rate among 77 bladder cancer patients.
- ImmunityBio sees a larger U.S. market after ANKTIVA wins expanded FDA approval.
ImmunityBio (IBRX) stock gained 1.12% to close at $9.91 on Wednesday, adding $0.11 after a volatile trading session. Shares advanced another 0.81% to $9.99 in after-hours trading as the company announced a major regulatory development. The FDA expanded ANKTIVA’s approval to include patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only tumors.
FDA Expands ANKTIVA Approval to More Bladder Cancer Patients
The U.S. Food and Drug Administration expanded ANKTIVA’s indication in combination with Bacillus Calmette-Guérin (BCG) therapy. The decision adds adults with papillary-only tumors to the treatment’s approved patient population. ImmunityBio can offer the combination to more patients with bladder cancer that no longer responds to BCG.
The latest decision follows the FDA’s initial approval of ANKTIVA in April 2024. That authorization covered patients with BCG-unresponsive NMIBC involving carcinoma in situ (CIS), with or without papillary tumors. However, the earlier indication 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. ImmunityBio now holds approval for ANKTIVA plus BCG across both CIS and papillary-only disease. Additionally, the broader label increases the treatment’s potential reach within the U.S. bladder cancer market.
Clinical Results Support ANKTIVA’s Expanded Use
The FDA reviewed existing scientific evidence supporting ANKTIVA’s effectiveness in treating BCG-unresponsive bladder cancer. This evidence included results from Cohort A of ImmunityBio’s QUILT-3.032 clinical trial. The trial evaluated ANKTIVA plus BCG in patients with CIS, with or without papillary tumors.
Among 77 patients, 62% achieved a complete response to treatment during the clinical study. Furthermore, 58% of responders maintained their response for at least 12 months. Another 40% maintained their response for at least 24 months, demonstrating sustained treatment benefits in some patients.
The treatment also showed a manageable safety profile, with most reported adverse events involving bladder-related symptoms. Common reactions included painful urination, frequent urination, and blood in the urine, mostly at mild or moderate levels. However, the prescribing information warns that delaying bladder removal surgery can allow potentially fatal metastatic cancer to develop.
ImmunityBio Targets a Larger Bladder Cancer Market
Non-muscle invasive bladder cancer accounts for approximately 80% of bladder cancer diagnoses in the United States. Furthermore, an estimated 85% to 90% of newly diagnosed NMIBC patients present with papillary disease. These figures highlight the substantial patient population affected by the disease.
Patients with high-grade papillary tumors face significant risks when their cancer stops responding to BCG treatment. Recurrence and disease progression create additional challenges, particularly for patients seeking alternatives to bladder removal surgery. Therefore, the expanded approval introduces another treatment option for eligible patients within this group.
ImmunityBio expects the broader indication to increase ANKTIVA’s addressable U.S. market beyond its original CIS population. The company also aims to build on commercial growth following the treatment’s initial approval in 2024. Meanwhile, the latest FDA decision strengthens ImmunityBio’s position in bladder cancer immunotherapy and expands its potential commercial opportunities.
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