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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › OTHER ANTINEOPLASTIC AGENTS › Antineoplastic cell and gene therapy
nadofaragene firadenovec
L01XL10
Forms & Strengths
- Intravesical suspension: 3 x 10^11 viral particles/mL (vpt/mL)
Adult Dosing
- Intravesical instillation: 75 mL (containing 3 x 10^11 vpt/mL) administered once every 3 months for up to 3 years or until unacceptable toxicity or recurrent high-grade recurrence.
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established.
Indications
- Treatment of adult 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.
Mechanism of Action
- Non-replicating adenoviral vector-based gene therapy that delivers the human interferon alfa-2b (IFNα-2b) gene into the patient's urothelial cells, leading to local expression and secretion of IFNα-2b protein, which exerts anti-tumor and immunomodulatory effects.
Contraindications
- Hypersensitivity to nadofaragene firadenovec or any of its components
- Patients with pre-existing immunodeficiency or immunosuppression
- Active urinary tract infection
Adverse Reactions
- Instillation site discharge
- Dysuria
- Micturition urgency
- Pollakiuria
- Hematuria
- Fatigue
- Chills
- Fever
- Myalgia
Drug Interactions
- No formal pharmacokinetic or drug-drug interaction studies have been conducted.
- Concomitant use with immunosuppressive agents may affect the efficacy or viral clearance, though systemic absorption is expected to be minimal.
Curated Content: Needs Vetting Before Put to Clinical Use