Oncology Drug Reference Sheet: Nadofaragene Firadenovec-Vncg

April 25, 2023 by Erin Dickman DNP, RN, OCN®

Under the U.S. Food and Drug Administration’s (FDA’s) fast-track approval process, nadofaragene firadenovec-vncg (Adstiladrin®) became the first gene therapy approved for the treatment (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin) of high-risk non-muscle invasive bladder cancer. Approximately 75% of newly diagnosed bladder cancers (https://pubmed.ncbi.nlm.nih.gov/32760227/) are classified as non-muscle invasive. Bacillus Calmette Guérin (BCG) has been used as first-line therapy for more than 20 years, but eventually 30%–50% of patients stop responding (https://www.urologytimes.com/view/bcg-unresponsive-nmibc-current-evidence-and-options), and nadofaragene firadenovec-vncg offers a new treatment option. FDA’s December 2022 approval (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin) was based on complete response (CR) and duration of response from Study CS-003, which demonstrated a 46% CR for at least one year.


Non-replicating adenoviral vector-based gene therapy

Mechanism of Action

Nadofaragene firadenovec-vncg delivers a copy of a gene (https://www.fda.gov/media/164029/download) that encodes for an antitumor protein. Once instilled, the gene creates a localized expression of the protein directly in the bladder urothelium, exposing the cancer cells to the protein for an extended period of time.


Treatment of adult patients with high-risk, BCG-unresponsive, non-muscle invasive bladder cancer (https://www.fda.gov/media/164029/download) with carcinoma in situ with or without papillary tumors


75 ml of nadofaragene firadenovec-vncg at a concentration of 3 x 1,011 viral particles (vp)/ml, instilled once every three months (https://www.fda.gov/media/164029/download)


Administer via intravesical instillation only. Specific administration training may be required. The full instillation process can be found on page 4 of the package insert (https://www.fda.gov/media/164029/download).

Additional administration information is available on pages 2–4 in the package insert (https://www.fda.gov/media/164029/download).

Adverse Reactions

During the drug’s clinical trials, more than 10% of patients reported (https://www.fda.gov/media/164029/download) instillation site discharge, fatigue, bladder spasm, micturition, hematuria, chills, pyrexia, and dysuria. More than 15% experienced (https://www.fda.gov/media/164029/download) increased glucose, triglyceride, and creatinine and decreased phosphate levels.

Nursing Considerations

Prior to starting therapy (https://www.fda.gov/media/164029/download):

After administration (https://www.fda.gov/media/164029/download), ensure patients and caregivers understand the safe-handling precautions to follow at home and when to call the healthcare team.

Patient Education

Delayed cystectomy may increase your risk (https://www.fda.gov/media/164029/download) for metastatic bladder cancer. All patients and their partners of reproductive potential should use contraception during and for six months following treatment (https://www.fda.gov/media/164029/download) with nadofaragene firadenovec-vncg. You may shed low levels of the medication (https://www.fda.gov/media/164029/download) in your urine for up to two days following treatment. Disinfect your urine for 30 minutes with an equal volume of bleach before flushing.

Special Considerations

Nadofaragene firadenovec-vncg is not recommended (https://www.fda.gov/media/164029/download) for patients who:

No information is available about the effects for pregnant patients and their fetus or breastfed infants of patients receiving nadofaragene firadenovec-vncg. Study populations (https://www.fda.gov/media/164029/download) were mostly aged 65 or older, and no conclusions can be drawn about safety or efficacy in younger age groups. No significant sex-based differences were noted (https://www.fda.gov/media/164029/download).

Safe Handling

Follow hazardous drug safe handling practices and medication exposure precautions. Because of the risk for splashing, wear an eye and face shield (https://www.ons.org/clinical-practice-resources/toolkit-safe-handling-hazardous-drugs-nurses-oncology) in addition to standard hazardous drug administration personal protective equipment. Treat any spills (https://www.fda.gov/media/164029/download) with a virucidal agent (e.g., sodium hypochlorite with 0.5% active chlorine, 6% hydrogen peroxide solution) for 30 minutes. Dispose materials (https://www.fda.gov/media/164029/download) that have contacted nadofaragene firadenovec-vncg in biohazard containers. Decontaminate nondisposable equipment (https://www.fda.gov/media/164029/download) according to your facility’s standard operating procedures.

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