Nadofaragene Firadenovec

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. Intravesical instillation of ADSTILADRIN results in cell transduction and transient local expression of the IFNα2b protein that is anticipated to have anti-tumor effects.

• ADSTILADRIN ® is indicated for the 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. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the 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.

• ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product [ see Description (11) ]. ADSTILADRIN is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product.contraindicated

Important Administration Instructions ADSTILADRIN is for intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration. Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN. ( 2.1 ) Administer ADSTILADRIN by intravesical instillation only. ( 2.1 ) ADSTILADRIN is not for intravenous use, topical use, or oral administration. ( 2 ) The dose is 75 mL of ADSTILADRIN at a concentration of 3 x 10 11 viral particles (vp)/mL, instilled once every three (3) months. ( 2.1 ) Allow ADSTILADRIN to be left in the bladder for 1 hour following instillation. ( 2.3 ) 2.1 Dose The recommended dose of ADSTILADRIN is 75 mL at a concentration of 3 x 10 11 viral particles (vp)/mL instilled once every three (3) months into the bladder via a urinary catheter [ see Dosage and Administration (2.2) ]. Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN. 2.2 Preparation and Handling ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling. Individuals who are immunosuppressed or immune-deficient, should not prepare, administer, or come into contact with ADSTILADRIN [ see Warnings and Precautions ( 5 ) ]. ADSTILADRIN is provided as a sterile frozen suspension. All four vials of ADSTILADRIN must be thawed and brought to room temperature (20°C to 25°C [68°F to 77°F]) prior to use. Do not expose the vials to higher temperatures (>25°C [77°F]). Protect from light. DO NOT refreeze.

Delaying cystectomy could lead to the development of metastatic bladder cancer, which can be lethal. ( 5.1 ) Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals. ( 5.2 ) 5.1 Risk of Muscle Invasive or Metastatic Bladder Cancer with Delayed Cystectomy Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Of the patients with CIS treated with ADSTILADRIN on Study CS-003 who underwent subsequent radical cystectomy and for whom pathologic data were available, 14% (n = 6) had muscle-invasive (T2 or greater) disease at cystectomy. Median time from persistence or recurrence of CIS to cystectomy in these patients was 235 days (range 38 to 582 days). Two additional patients who did not undergo cystectomy experienced progression to muscle-invasive disease during the treatment period. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.

The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ADSTILADRIN was evaluated in Study CS-003, a multicenter, single-arm, open-label study in 157 U.S. patients [ see Clinical Studies (14 ) ] with high-risk BCG‑unresponsive NMIBC, 107 of whom had BCG-unresponsive carcinoma in situ (CIS) with or without papillary tumors. Patients received 75 mL (3 x 10 11 vp/mL) ADSTILADRIN administered intravesically once every 3 months for up to 12 months [ see Clinical Studies (14 ) ]. All patients with an absence of high-risk recurrence or progression were offered continued treatment every 3 months beyond 12 months. The median number of instillations of ADSTILADRIN was 2 (range 1 to 5). Serious adverse reactions occurred in 11% of patients who received ADSTILADRIN.

Immunocompromise/immunodeficiency: Avoid in patients with immunocompromise or immunodeficiency. ( 8 ) 8.1 Pregnancy Risk Summary Adequate and well-controlled studies with ADSTILADRIN have not been conducted in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with ADSTILADRIN. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of ADSTILADRIN in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ADSTILADRIN and any potential adverse effects on the breastfed infant from ADSTILADRIN or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential No nonclinical or clinical studies were performed to evaluate the effect of ADSTILADRIN on fertility. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating ADSTILADRIN.

Metabolism

Nonclinical data Human IFN protein in urine, and vector-specific DNA in blood and tissue samples, were detectable following ADSTILADRIN dosing in monkeys, with higher levels at higher doses. All monkeys had vector-specific DNA in the bladder tissue at necropsy on Days 8 and 98 (i.e., seven days after the first and second dose, respectively).

1. 1Instillation Site Discharge10624%
2. 2Bladder Spasm6114%
3. 3Pyrexia398.7%
4. 4Fatigue347.6%
5. 5Disease Recurrence286.3%
6. 6Micturition Urgency276.1%
7. 7Chills265.8%
8. 8Drug Ineffective265.8%
9. 9Expulsion Of Medication235.2%
10. 10Influenza Like Illness214.7%
11. 11Dysuria184.0%
12. 12Haematuria184.0%
13. 13Pain184.0%
14. 14Headache153.4%
15. 15Pollakiuria132.9%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Nadofaragene Firadenovec as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
  Not yet recruiting · Phase 2 · Interventional · 33 enrolled · University of Washington
  NCT07332351updated 2026-06-08
• Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
  Recruiting · Phase 3 · Interventional · 454 enrolled · Ferring Pharmaceuticals
  NCT06510374updated 2026-05-22
• A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
  Recruiting · Phase 3 · Interventional · 250 enrolled · Ferring Pharmaceuticals
  NCT06545955updated 2026-05-22
• A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
  Recruiting · Phase 3 · Interventional · 125 enrolled · Memorial Sloan Kettering Cancer Center
  NCT06929286updated 2026-05-11
• Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
  Recruiting · Phase 1 · Phase 2 · Interventional · 20 enrolled · Ferring Pharmaceuticals
  NCT06668493updated 2026-05-08
• Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma
  Completed · Phase 3 · Interventional · 53 enrolled · Ferring Ventures Limited
  NCT03710876updated 2026-04-21
• ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
  Terminated · Observational · 202 enrolled · Ferring Pharmaceuticals
  NCT06026332updated 2026-02-17
• Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
  Active not recruiting · Phase 3 · Interventional · 25 enrolled · Ferring Pharmaceuticals
  NCT05704244updated 2025-08-28
• A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.
  Withdrawn · Phase 4 · Interventional · 0 enrolled · Ferring Pharmaceuticals
  NCT06390111updated 2024-11-22

Frequently asked questions

How does Nadofaragene Firadenovec work?

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. Intravesical instillation of ADSTILADRIN results in cell transduction and transient local expression of the IFNα2b protein that is anticipated to have anti-tumor effects.

What is Nadofaragene Firadenovec used for?

According to FDA labeling, Nadofaragene Firadenovec carries indications including: ADSTILADRIN ® is indicated for the 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. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nadofaragene Firadenovec?

Nadofaragene Firadenovec is classified as Antineoplastic cell and gene therapy, Gene Transcription Modulation.

What are the brand names for Nadofaragene Firadenovec?

Nadofaragene Firadenovec is marketed under brand names including Adstiladrin.

What are the contraindications for Nadofaragene Firadenovec?

Nadofaragene Firadenovec labeling lists contraindications including: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product [ see Description (11) ]. ADSTILADRIN is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product.. Always consult the full prescribing information and a clinician.