Anktiva (nogapendekin alfa inbakicept-pmln intravesical solution) — Medica
Non-muscle invasive bladder cancer (carcinoma in situ with or without papillary tumors)
Initial criteria
- age ≥ 18 years
- high risk Bacillus Calmette-Guerin (BCG) unresponsive disease
- has carcinoma in situ (CIS)
- Anktiva is used in combination with BCG
- prescribed by or in consultation with a urologist or an oncologist
Reauthorization criteria
- patient has an ongoing complete response defined as ONE of the following: (a) negative cystoscopy AND [negative urine cytology OR malignant urine cytology if cancer found in the upper tract or prostatic urethra and random bladder biopsies are negative]; OR (b) positive cystoscopy with biopsy-proven benign or low-grade Ta non-muscle invasive bladder cancer and negative urine cytology
- Anktiva is used in combination with BCG
- prescribed by or in consultation with a urologist or an oncologist
Approval duration
initial: 6 months; reauthorization: 3 months