Biologics

ImmunityBio’s Anktiva sBLA for Expanded Use Accepted by FDA

FDA has accepted for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease but without carcinoma in situ (CIS). The agency has set a user fee review action target of 1/6/2027.

The supplemental filing seeks to broaden the currently approved indication for ANKTIVA plus BCG, which won FDA approval 4/2024 for adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.

According to ImmunityBio, FDA said in its filing communication that the application relies on results from the QUILT-3.032 Cohort B study along with scientific literature suggesting papillary NMIBC shares overlapping biological and clinical characteristics with CIS disease. The agency indicated that its review will focus on whether those similarities justify extrapolating efficacy findings from the already approved CIS population to patients with papillary-only disease.

The filing comes amid broader debate over how to evaluate therapies for papillary-only NMIBC, particularly because many studies in the setting are conducted as single-arm trials rather than randomized studies.

ImmunityBio pointed to discussions during an FDA workshop held May 18 titled “Contemporary Issues in Non-Muscle Invasive Bladder Cancer (NMIBC) Trial Design and Interpretation.” According to the company, panelists at the meeting stated that CIS and papillary disease may arise from the same cancer-inducing clone and are frequently treated similarly in clinical practice. The company also noted that the National Comprehensive Cancer Network earlier this year granted a Category 2A recommendation for intravesical Anktiva plus BCG in patients with BCG-unresponsive papillary disease alone.

The submission is supported by data from the Phase 2/3 QUILT 3.032 Cohort B trial involving 80 patients with high-grade papillary-only NMIBC. ImmunityBio said the study achieved its primary endpoint, with a 12-month disease-free survival rate of 58.2%.

The company also highlighted secondary endpoint data intended to demonstrate durable bladder preservation and delayed progression to muscle-invasive disease. According to ImmunityBio, progression-free survival was 94.9% at 12 months and 82% at 36 months, while cystectomy-free survival was 92.2% at one year and 83.1% at three years. Disease-specific survival at 36 months was reported at 96%.

ImmunityBio said the safety profile observed in the supplemental filing was consistent with previously reported data for Anktiva plus BCG and aligned with the known safety profile of BCG alone.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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