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MECHANISM OF ACTION

ADSTILADRIN Offers
a Novel Approach
to Treat NMIBC

From instillation to immune activation1

ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy.1

STEP 1

Gene delivery

ADSTILADRIN delivers the
interferon alpha 2B gene (IFNα2b) directly into
the bladder’s
urothelial cells.2

Step 2

Create localized interferon
microfactories

The gene instructs both healthy and cancerous bladder cells to temporarily produce high levels of IFNα2b—a
potent immune activator. The cells then act like microfactories, generating sustained local IFNα2b expression in the bladder wall.2,3

Step 3

Activate the immune system and kill the cancer

The IFNα2b protein
is well known to activate
both the innate (fast,

general)
and adaptive (targeted,

long-lasting) immune responses, working to slow tumor growth and
kill cancer
cells in the bladder while also exerting antitumor effects.2

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ADSTILADRIN Is a Localized Treatment for Localized Tumors

ADSTILADRIN is a non-replicating, vector-based gene therapy that works with the patient’s own immune system to fight bladder cancer. It delivers the IFNα2b gene to bladder urothelial cells. It does not alter any existing genes in the body like some other gene therapies.1,2

Patients who respond
to treatment can continue 

taking ADSTILADRIN quarterly to maintain
anticipated antitumor and immunomodulatory

effects1,2,4

Abbreviation: NMIBC, non–muscle-invasive bladder cancer.

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References: 1. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; October 2025. 2. Narayan VM, Dinney CPN. Intravesical gene therapy. Urol Clin North Am. 2020;47(1):93-101. doi:10.1016/j.ucl.2019.09.011 3. Steinmetz AR, Mokkapati S, McConkey D, et al. The evolution of nadofaragene firadenovec: a review and the path forward. Bladder Cancer. 2024;10(2):105-112. doi:10.3233/BLC-230083 4. Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of intravesical nadofaragene firadenovec for patients with Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: 5-year follow-up from a phase 3 trial. J Urol. 2024;212(1):1-12. doi:10.1097/JU.0000000000004020

Important Safety Information

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

  • Risk 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. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
  • 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.

DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: 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).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-10881-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING1-888-FERRING.

Please see full Prescribing Information for ADSTILADRIN.

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New Clinical Data

NEW CLINICAL
DATA

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