FDA Expands Approval of ImmunityBio's Anktiva

By Philip Seaworth • Thursday, October 15 01:43 • Permanent Link

ImmunityBio said the FDA expanded approval of Anktiva in combination with BCG to cover adult patients with BCG-unresponsive non-muscle-invasive bladder cancer with papillary-only tumors, broadening the drug’s reach beyond the April 2024 approval for carcinoma in situ, with or without papillary tumors.

The company said the new label now covers all patients with BCG-unresponsive NMIBC. Papillary disease accounts for about 85% of the NMIBC patient population, according to the release.

The approval was supported by data from the QUILT-3.032 trial. In cohort A, 62% of 77 patients achieved a complete response. Among those responders, 58% maintained a response for at least 12 months and 40% maintained a response for at least 24 months.

ImmunityBio said the combination’s most common treatment-related adverse events were bladder-instillation related, including dysuria, pollakiuria and hematuria, and that most were grade 1 or 2.

The company also highlighted the market impact of the label expansion, saying the broader approval materially increases Anktiva’s U.S. addressable patient population beyond the previously approved CIS population. The market has reacted to these announcements by moving the company's shares -3.16% to a price of $9.80. For more information, read the company's full 8-K submission here.

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