RegulatoryCompany release

FDA widens Anktiva label in BCG-unresponsive bladder cancer as ImmunityBio's Q3 sales hit $48.7m

🇺🇸 ImmunityBio, Inc. (IBRX) · Mon 09 Nov 2026

ImmunityBio says the FDA has broadened Anktiva's indication to include papillary-only tumours, as quarterly net product revenue rose 53% to $48.7 million.

ImmunityBio reported on 9 November 2026 that the US Food and Drug Administration approved, on 14 October, a supplemental biologics licence application (sBLA) expanding the indication for Anktiva used with BCG. The label now covers adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), including those with papillary-only tumours.

The company also announced an approval in Israel, which it counts as its 35th globally. It said the first patients in Europe have been treated with the product, though the summary available does not specify the regulatory route or the countries involved.

On the development side, ImmunityBio said the QUILT-2.005 cohort in BCG-naïve patients met its primary endpoint. The company plans to submit an sBLA for that population in the fourth quarter of 2026. Detailed results were not included in the information available to VigiEye.

Financially, Anktiva net product revenue for the third quarter of 2026 reached $48.7 million, a 53% increase on the same period a year earlier, according to the company's release.

What it means for your team

  • Regulatory teams should note the label now explicitly includes papillary-only BCG-unresponsive NMIBC, a change in the eligible population in the US.
  • A Q4 2026 sBLA in BCG-naïve disease would, if filed, open a further indication review at the FDA; timing remains the company's plan, not a regulatory commitment.
  • Market-access teams may see wider patient eligibility and reported sales growth as inputs for payer discussions, pending full label details.
  • Pharmacovigilance teams should watch for updated prescribing information and any new safety data tied to the expanded population.

Company's press release (SEC filing): ImmunityBio, Inc. ↗

Article written by VigiEye from the official source (ImmunityBio, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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