NADOFARAGENE FIRADENOVEC-VNCG INJ,SUSP
Clinical Criteria Summary
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Exclusion Criteria
- Hypersensitivity to interferon alpha
- Current or previous evidence if muscle-invasive or metastatic bladder cancer
- Upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra
- Pregnancy in patients of reproductive potential
Inclusion Criteria
- Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC)
- Carcinoma in situ (CIS) with or without papillary tumors (Ta or T1 high-grade tumors)
Additional Inclusion Criteria
- Care is provided by a VA/VA Community Care urology provider or in consultation with a VA urology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care have been discussed and documented
Contraception & Counseling Requirements
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 6 months after stopping treatment
BCG-Unresponsive Definition
- Received 2 courses of BCG within 12 months (5 of 6 induction instillations and at least 2 of 3 maintenance doses OR at least 2 of 6 instillations of a second induction when maintenance not given)
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Indication & Patient Population
- • Treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
- • Applicable to patients with CIS ± Ta/T1 disease.
Administration & Dosing Requirements
- • Intravesical administration via bladder instillation.
- • Dosing interval: Every 3 months.
- • Adequate prior BCG therapy required: Administration of at least five of six doses of induction course plus either at least two of three doses of maintenance or at least two of six doses of a second induction course.
- • Pre-treatment with an anticholinergic agent is recommended prior to each instillation to minimize irritative symptoms.
Safety, Contraindications & Precautions
- • Contraindicated in patients with prior hypersensitivity to interferon alpha or any component of the product.
- • No boxed warnings.
- • Monitor for increased glucose (Grade 3 or 4 occurred in 6% of study patients).
- • Advise patients regarding reproductive potential, risk to fetus, and breastfeeding.
- • Verify pregnancy status prior to use.
Storage & Handling Requirements
- • Must be stored in a freezer at ≤-60°C.
- • May be stored for up to 3 months at -25°C to -15°C without exceeding carton expiration date.
- • Once removed from freezer, store for 24 hours at room temperature or refrigerated.
- • Protect vials from light.
Monitoring & Follow-up
- • Mandatory bladder biopsy at 1 year.
- • Clinical response assessment includes complete response in CIS cohort and high-grade recurrence-free survival.