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FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

Key Takeaway: ImmunityBio, Inc. announced that the FDA has expanded the approval for ANKTIVA® to include treatment for BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors. This expansion allows the use of ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for a broader patient population. The updated indication enhances treatment options for patients suffering from this condition.

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POSITIVE FACTORS

  • FDA approval expands treatment options for patients.
  • ANKTIVA now covers both papillary and CIS disease.
  • ImmunityBio strengthens its position in bladder cancer therapy.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+48%
120-day peak, hindsight
Typical move
7%
average across 3 past catalysts
Cash runway
~14 mo
Low dilution risk
Lead asset
Nogapendekin alfa inbakicept
NDA/BLA · NSCLC Stage IV

Full Press Release Details

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive NMIBC with papillary-only tumors. The expanded FDA label reads as follows: ANKTIVA, in combination with Bacillus Calmette-Guérin (BCG), is in

Frequently Asked Questions

What is ANKTIVA® used for?

ANKTIVA® is used in combination with BCG for treating BCG-unresponsive NMIBC.

What recent approval did ANKTIVA® receive?

ANKTIVA® received FDA approval to treat patients with papillary-only tumors.

Who announced the FDA approval for ANKTIVA®?

ImmunityBio, Inc. announced the FDA approval for ANKTIVA®.

What does NMIBC stand for?

NMIBC stands for non-muscle-invasive bladder cancer.

Last updated: Oct 14, 2026