FDA Approves Anktiva Plus BCG for Certain Bladder Cancer Subset

Anktiva plus BCG is used to treat certain patients with BCG-unresponsive non-muscle-invasive bladder cancer.

The Food and Drug Administration (FDA) has approved Anktiva (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, the agency announced.

The approval was based on the QUILT-3.032 trial of 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease who had undergone transurethral resection, with patients receiving Anktiva with BCG followed by maintenance therapy for up to 37 months.

The complete response rate (CR; the disappearance of cancer) was 62%, with 58% of patients having a CR duration of response of at least 12 months and 40% having a duration of response of at least 24 months.

The most common side effects occurring in at least 15% of patients, including laboratory test abnormalities, included increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

According to the FDA, the recommended dosage of Anktiva is 400 micrograms administered intravesically with BCG weekly for six weeks as induction therapy and a second induction course may be administered if patients do not experience complete response at month 3. Then, the recommended maintenance dose is 400 micrograms administered intravesically with BCG once a week for three weeks at months 4, 7, 10, 13 and 19, totaling 15 doses. Maintenance instillations with BCG may be administered for patients with an ongoing complete response at month 25 or later once a week for three weeks at months 25, 31 and 37 for up to nine additional instillations.

The agency advised that treatment be discontinued if the disease persists after the second induction, recurs or progresses, or if patients experience unacceptable toxicity, with a maximum treatment duration of 37 months.

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