Bladder cancer remains a significant health challenge worldwide, with thousands of new cases diagnosed annually. Among various types, non-muscle invasive bladder cancer (NMIBC) poses a unique treatment dilemma, especially when it becomes high-risk and unresponsive to Bacillus Calmette-Guérin (BCG) therapy. In such cases, patients often face limited treatment options, sometimes leading to the need for radical cystectomy (bladder removal). However, a revolutionary therapy, Adstiladrin (nadofaragene firadenovec-vncg), has emerged as a beacon of hope for patients battling high-risk NMIBC.
This blog explores what Adstiladrin is, how it works, its benefits, side effects, and what patients need to know before considering it as a treatment option.
Understanding High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
Bladder cancer is broadly categorized into muscle-invasive and non-muscle-invasive forms. NMIBC is confined to the inner layers of the bladder and has a relatively better prognosis. However, high-risk NMIBC is particularly challenging to manage due to its increased likelihood of recurrence and progression.
Patients with high-risk NMIBC often receive intravesical BCG therapy—a standard immunotherapy approach that stimulates the immune system to attack cancer cells. Unfortunately, some patients develop BCG-unresponsive NMIBC, meaning their cancer returns or persists despite adequate BCG treatment. Traditionally, the next step for these patients has been radical cystectomy, a highly invasive procedure with significant impact on quality of life. Adstiladrin offers a promising alternative for such patients.
What is Adstiladrin?
Adstiladrin (nadofaragene firadenovec-vncg) is an FDA-approved gene therapy designed for high-risk BCG-unresponsive NMIBC. It represents a groundbreaking advancement in the treatment landscape, providing a non-surgical option that stimulates the body’s immune system to fight bladder cancer.
How Does Adstiladrin Work?
Adstiladrin is a gene therapy drug delivered directly into the bladder through intravesical instillation (via a catheter). It uses a modified adenovirus to introduce a functional copy of the IFN-α2b (interferon alfa-2b) gene into bladder cells. Once inside the bladder lining, this gene helps the body produce interferon proteins, which stimulate the immune system to attack and destroy cancer cells.
Key Mechanism of Action
Gene Delivery – Adstiladrin carries a genetic code that instructs bladder cells to produce interferon-alpha-2b.
Immune Activation – The body starts producing its own cancer-fighting interferon, boosting immune response.
Tumor Suppression – This interferon helps inhibit tumor growth and prevent recurrence.
Benefits of Adstiladrin
Adstiladrin provides several advantages over traditional treatments for high-risk NMIBC:
1. Non-Surgical Alternative to Radical Cystectomy
For patients who are unfit or unwilling to undergo bladder removal surgery, Adstiladrin offers a bladder-preserving option.
2. High Efficacy Rates
Clinical trials have demonstrated promising results:
Approximately 51% of patients achieved a complete response (CR) at three months after treatment.
At one year, around 24% of patients remained cancer-free.
Many patients experienced prolonged recurrence-free periods without needing cystectomy.
3. Less Frequent Administration
Unlike BCG or chemotherapy, which often require multiple instillations per week, Adstiladrin is given once every three months.
4. Minimal Systemic Side Effects
Since the therapy works locally within the bladder, systemic side effects (those affecting the whole body) are minimal compared to traditional chemotherapy or immunotherapy.
Potential Side Effects of Adstiladrin
While Adstiladrin is generally well tolerated, patients may experience some mild to moderate side effects, including:
Bladder irritation – Burning sensation, urgency, or discomfort while urinating
Urinary tract infections (UTIs)
Fatigue
Fever or flu-like symptoms
Blood in urine (hematuria)
Bladder pain or spasms
Most of these side effects resolve on their own or can be managed with medications.
Who is Eligible for Adstiladrin?
Adstiladrin is approved for adult patients with high-risk NMIBC that is BCG-unresponsive, including:
Carcinoma in situ (CIS) with or without papillary tumors
Patients who have not responded to BCG therapy
Those who wish to avoid bladder removal surgery
However, it is not recommended for patients with muscle-invasive bladder cancer (MIBC) or those with certain immune deficiencies.
How is Adstiladrin Administered?
Adstiladrin is delivered via intravesical instillation, meaning it is placed directly into the bladder through a catheter.
Administration Process:
The patient empties their bladder before treatment.
A catheter is inserted to instill Adstiladrin into the bladder.
The patient holds the drug in their bladder for one hour, allowing it to work.
After one hour, the patient voids the bladder naturally.
The treatment is repeated every three months.
What Should Patients Expect?
Before Treatment:
Patients may need urinary tests and a cystoscopy to confirm eligibility.
Discuss any current medications or allergies with the doctor.
During Treatment:
Some patients experience mild discomfort during bladder instillation.
Holding the drug for one hour may cause temporary urgency.
After Treatment:
Increased urination, mild burning, or bladder irritation is common but temporary.
Avoid sexual activity or heavy physical activity for a short period.
Follow-up cystoscopy and urine cytology tests are needed to monitor response.
Conclusion: A New Era in Bladder Cancer Treatment
For patients with high-risk BCG-unresponsive NMIBC, Adstiladrin represents a major breakthrough, offering hope for bladder preservation without immediate radical surgery. While it may not work for every patient, its high efficacy, convenient administration, and minimal side effects make it a game-changer in bladder cancer management.
Please write to enquire@grgonline.com to learn how GRG Health is helping clients gather more in-depth market-level information on such topics.
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