Adstiladrin (nadofaragene firadenovec-vncg) — Medica
high-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with high-grade papillary Ta/T1 tumors without CIS
Initial criteria
- age ≥ 18 years
 - Patient has high-risk Bacillus Calmette-Guerin (BCG)-unresponsive disease
 - Patient meets ONE of the following: (a) carcinoma in situ (CIS); OR (b) high-grade papillary Ta/T1 tumors without CIS
 - Medication is prescribed by or in consultation with a urologist or an oncologist
 
Reauthorization criteria
- Patient meets ONE of the following: (a) in remission both on cytology and cystoscopic examination; OR (b) cytology-positive, imaging- and cystoscopy-negative, recurrent or persistent disease
 - Medication is prescribed by or in consultation with a urologist or an oncologist
 
Approval duration
initial: 4 months; reauthorization: 3 months