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Opinion|Videos|October 21, 2026
Michael Cookson, MD, reacts to Anktiva’s expanded approval in NMIBC
Author(s)Michael S. Cookson, MD, MMHC, FACS
Fact checked by: Hannah Clarke
Michael S. Cookson, MD, MMHC, FACS, discusses how Anktiva’s expanded FDA approval may broaden bladder-preserving treatment options for BCG-unresponsive papillary-only NMIBC.
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In this video, Michael S. Cookson, MD, MMHC, FACS, discusses the significance of the FDA’s expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for patients with BCG-unresponsive high-risk non–muscle-invasive
According to Cookson, the FDA’s expanded approval of nogapendekin alfa inbakicept plus BCG addresses an unmet need for patients with BCG-unresponsive NMIBC whose disease presents as papillary tumors without carcinoma in situ (CIS). Historically, treatment options in this setting have been narrowly indicated for patients with CIS, although papillary tumors representing the more common presentation of noninvasive disease. Cookson explains that expanding the indication to include papillary-only disease broadens the population eligible for bladder-preserving treatment options.
The expanded indication may also simplify treatment access by reducing potential barriers related to insurance coverage and payer requirements. Because coverage decisions often follow FDA-approved indications and associated pathology classifications, expanded eligibility for nogapendekin alfa inbakicept plus BCG to patients with papillary-only disease may make it easier for clinicians to use this regimen in this setting. Cookson notes that the approval eliminates the need to identify concomitant CIS for patients who otherwise meet the criteria for BCG-unresponsive disease.
“This is going to help us to open up a significant new group of patients for these potentially bladder-preserving, avoidance of cystectomy-type treatments,” Cookson noted.
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REFERENCE
1. FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. US Food & Drug Administration. October 14, 2026. Accessed October 14, 2026.
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