FDA Widens Approval for Anktiva in Bladder Cancer

The FDA has approved an expanded indication for nogapendekin alfa inbakicept pmln, marketed as Anktiva, for use with Bacillus Calmette Guérin, known as BCG, in adults with BCG unresponsive non muscle invasive bladder cancer. This is an approved medication decision, not a research preview, according to the FDA's announcement.

Previously, the drug was indicated for patients with carcinoma in situ, with or without papillary tumors. The new indication adds patients with high grade papillary only tumors, a related but architecturally distinct form of aggressive urothelial cancer. The FDA based this extension on data from Cohort A of the QUILT 3.032 trial, a single arm study of 77 patients that reported a 62 percent complete response rate, with 58 percent of responders maintaining that response for at least 12 months and 40 percent for at least 24 months.

Common adverse effects included increased creatinine, dysuria, hematuria, urinary frequency, urgency, urinary tract infections, elevated potassium, musculoskeletal pain, chills, and fever. The agency also flagged a warning that delaying cystectomy when indicated can allow progression to metastatic disease, which can be fatal. Dosing follows a structured induction and maintenance schedule administered directly into the bladder alongside BCG, for a maximum treatment duration of 37 months.

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