The FDA approved an adenovirus gene therapy for the treatment of bladder cancer

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Dr.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said the approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle-invasive bladder cancer who do not respond to BCG therapy
.
This approval addresses an area of urgent need
.
The FDA remains committed to promoting the development and approval
of safe and effective cancer treatments.

Bladder cancer is a relatively common type of cancer in which abnormal bladder cancer cells can invade and destroy normal body tissues
.
Over time, these cancer cells also metastasize
in the body.
Most newly diagnosed bladder cancers (75%-80%) are classified as non-muscle-invasive bladder cancer (NMIBC), a type of cancer
that has grown through the lining of the bladder but has not yet invaded the muscle layer.
This type of cancer is associated with
a high recurrence rate (30%-80%) and the risk of progression to aggressive and metastatic cancer.

Treatment and care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC), including carcinoma in situ (abnormal cancer cells are found where cancer cells first formed but have not spread to nearby tissue), are often treated with surgical removal of the tumor and BCG to reduce the risk of
cancer recurrence.
There are few effective treatment options
for patients who do not respond to BCG.

According to the 2020 global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC), the incidence of bladder cancer ranked 10th in the world, with 570,000 new patients per year, of which 440,000 were mostly men, accounting for 77%.

The approved Adstiladrin therapy safety and efficacy data are from a multicenter clinical trial that enrolled 157 high-risk BCG non-responsive NMIBC patients, 98 of whom had BCG non-responsive carcinoma in situ with or without papillary tumors
.
Patients receive Adstiladrin every three months, injected into the bladder through a catheter for 12 months, or until there is an unacceptable level of toxicity to treatment or recurrent NMIBC
.

Adstiladrin therapy uses a non-replicating adenovirus vector expressing the interferon α-2b gene, and a urinary catheter is injected into the bladder every three months, causing bladder parietal cells to produce interferon α-2b protein.

Overall, 51% of patients achieved complete remission (disappearance of all signs of cancer seen on cystoscopy, tissue biopsy, and urine) after treatment with Adstiladrin, with a median duration of response of 9.
7 months, and 46% of respondent patients maintained a complete response
for at least one year.
The most common adverse effects associated with treatment with Adstiladrin include bladder voiding, fatigue, bladder spasm, urgency, haematuria, chills, fever, and dysuria
.