The Food and Drug Administration expanded approval of ImmunityBio's nogapendekin alfa inbakicept-pmln, marketed as Anktiva, on Wednesday. The approval covers Anktiva alongside Bacillus Calmette-Guerin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer. The revised indication adds high-grade papillary-only disease to the previous indication for carcinoma in situ (CIS) with or without papillary tumors.
The FDA broadened the indication after evaluating available scientific information. High-grade papillary tumors and CIS have distinct architectural growth features. Both forms represent aggressive urothelial carcinomas that frequently coexist and create diagnostic challenges for pathologists. Both forms carry high risks of recurrence and progression in the BCG-unresponsive setting. The FDA concluded that proven clinical efficacy in CIS patients extends directly to high-grade papillary tumors because both forms carry those risks.
Earlier data from Cohort A of the multicenter, single-arm QUILT-3.032 trial established Anktiva's efficacy in 77 patients. The patients had high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS following transurethral resection. Participants received intravesical instillations during induction and maintenance for up to 37 months. Evaluators assessed therapeutic success through cystoscopy, urine cytology and biopsy. The regimen achieved a 62% complete response rate. Among responders, 58% maintained the response for at least 12 months. Among responders, 40% maintained the response for 24 months or longer.
Under the approved protocol, providers administer 400 micrograms of Anktiva intravesically alongside BCG once weekly for six weeks as induction therapy. Clinicians can administer a second six-week induction course if patients have residual CIS or high-grade Ta tumors at month three. Maintenance starts at month four and consists of weekly doses for three weeks during months 4, 7, 10, 13 and 19, totaling 15 doses. Patients without high-grade disease at month 25 can receive three-week cycles during months 25, 31 and 37, adding up to nine doses. Providers must stop therapy upon disease recurrence, progression, unacceptable toxicity or persistence after a second induction course. The maximum treatment duration is 37 months.
ImmunityBio shares rose following the announcement. Benzinga Pro data showed ImmunityBio shares up 5.36% at $10.32 at publication on Wednesday. Trading volume climbed to 19.72 million shares, nearly 1.9 times the 100-day average of 10.38 million shares.
FDA Expands Approval for ImmunityBio's Anktiva for Bladder Cancer
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Summary
FDA approved ImmunityBio's Anktiva for bladder cancer on Wednesday, expanding its use to include high-grade papillary-only disease. Trading volume surged as shares climbed 5.36% to $10.32. On-chain data shows 19.72 million shares exchanged. The drug now pairs with BCG for adults, based on a 62% complete response rate in 77 patients from the QUILT-3.032 trial.
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