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Intravesical Gene Therapy with ADSTILADRIN®

Diagnosis:

Non-Muscle Invasive Bladder Cancer (includes Ta, T1, CIS tumors)

Treatment Category:

Gene therapy

Treatment:

Gene therapy

Suitable for:

Suitable for adults with NMIBC who no longer respond to BCG therapy, including adults with:

  • Persistent disease following adequate BCG therapy
  • Recurrent disease after an initial tumor-free state following adequate BCG therapy
How it works:

The novel gene therapy is administered directly into the bladder, or intravesically. It consists of a non-replicating virus that contains the gene to make interferon alfa-2b, an important immune system protein. The virus is mixed with a liquid and administered into the bladder where it targets the patient’s own bladder wall cells to enhance the body’s natural defenses to fight bladder cancer. The high local expression of interferon alfa-2b protein is typically sustained for 1 to 2 weeks and does not build into the patient’s DNA.

 

How it is typically used:

Used to treat adult patients with NMIBC with CIS who no longer respond to BCG therapy

How it is administered:

Liquid medication is delivered directly into the bladder via a thin tube called a urinary catheter. Administered once every three months in the urologist or uro-oncologist office

Side effects:
  • Urinary discharge
  • Fatigue
  • Bladder spasm
  • Urgency to urinate
  • Blood in the urine

 

Is this given with other treatments?

Additional information:

https://bcan.org/intravesical-therapy/

Additional 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 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Disclaimer: Information and services provided by the Bladder Cancer Advocacy Network (BCAN) are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. If you are ill, or suspect that you are ill, seek professional medical attention immediately! BCAN does not recommend or endorse any specific physicians, treatments, procedures or products even though they may be mentioned on this site.

  • You can search for a clinical trial by bladder cancer disease state, state of residence and you can also look for trials nearest to you.

    CLINICAL TRIALS

  • Our interactive map shows the total numbers of cases anticipated in each of the 50 states as well as additional helpful bladder cancer resources in each state.

    BLADDER CANCER BY STATE

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