FDA提前约3个月批准Anktiva扩展至单纯乳头状(无CIS)的BCG无应答NMIBC，IBRX盘中涨约5%

The Food and Drug Administration (FDA) expanded its approval on Wednesday for ImmunityBio Inc.’s (NASDAQ:IBRX) nogapendekin alfa inbakicept-pmln (Anktiva).
Following the announcement, ImmunityBio stock rose more than 5%. Trading volume climbed to 19.72 million shares, nearly 1.9 times the 100-day average of 10.38 million shares.
Regulators cleared the drug alongside Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The decision revises the previous indication—which covered carcinoma in situ (CIS) with or without papillary tumors—to include high-grade papillary-only disease.
FDA Extrapolates Trial Efficacy To Papillary Tumors
Agency officials broadened the indication after evaluating available scientific information. While high-grade papillary tumors and CIS display distinct architectural growth features, both represent aggressive urothelial carcinomas that frequently coexist and challenge pathologists during diagnosis.
Because both forms carry high recurrence and progression risks in the BCG-unresponsive setting, the FDA concluded that proven clinical efficacy in CIS patients extends directly to high-grade papillary tumors.
QUILT-3.032 Trial Demonstrates Durable Patient Responses
Earlier clinical data from Cohort A of the multicenter, single-arm QUILT-3.032 trial established the drug’s efficacy in 77 patients with high-risk, BCG-unresponsive NMIBC with CIS following transurethral resection.
Participants received intravesical instillations during induction and maintenance for up to 37 months.
Evaluators determined therapeutic success through cystoscopy, urine cytology, and biopsy.
The regimen achieved a 62% complete response rate. Among responders, 58% maintained that response for at least 12 months, while 40% sustained response duration for 24 months or longer.
Recommended Dosing And Administration Protocol
Under the approved protocol, medical providers administer 400 mcg intravesically alongside BCG once weekly for six weeks as induction therapy.
Clinicians can deliver a second six-week induction round if patients present residual CIS or high-grade Ta tumors at month three.
Maintenance begins at month four with weekly doses for three weeks across months 4, 7, 10, 13, and 19, totaling 15 doses.
Patients without high-grade disease at month 25 can receive three-week cycles at months 25, 31, and 37, adding up to nine additional doses.
Providers must halt therapy upon disease recurrence, progression, unacceptable toxicity, or persistence after a second induction. The maximum treatment duration spans 37 months.
IBRX Price Action: ImmunityBio shares were up 5.36% at $10.32 at the time of publication on Wednesday, according to Benzinga Pro data.
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