Intravesical Therapy

December 5, 2024

What is intravesical therapy?

Intravesical therapy is a treatment that puts medicine directly into the bladder. This way, the medicine goes straight to the cancer cells without affecting the rest of the body. It is helpful for treating tumors that are hard to remove, like CIS, and intermediate or high-risk non-muscle invasive bladder cancer (NMIBC), which is more likely to return after tumor removal surgery. The treatment is given through a small tube called a catheter so that it has direct contact with the bladder wall.

Intravesical Therapy for NMIBC (non-muscle invasive bladder cancer) includes:

BCG (Bacille Calmette-Guerin) Immunotherapy

BCG is a type of immunotherapy that uses weakened bacteria to activate the immune system against bladder cancer cells. It’s administered directly into the bladder for patients with high-grade, non-invasive bladder cancers, like CIS or T1 tumors that have not spread into the muscle. BCG is usually given in an initial six-week cycle, and doctors may recommend additional maintenance doses to help reduce the risk of cancer coming back. BCG has been effective for many patients, though it can cause side effects like bladder irritation, fever, or mild bleeding.

What about the current BCG shortage?

Learn more about the BCG shortage here.

ImmunityBio is working to address the shortage and ongoing patient need of Bacillus Calmette-Guérin (BCG) by developing a new form of BCG called recombinant mycobacterium BCG (or rBCG) and making it available in the United States both through clinical trials and an Expanded Access program for patients that do not qualify for clinical trials.

Adstiladrin (Nadofaragene Firadenovec-vncg)

Adstiladrin is a gene therapy approved for patients with carcinoma in situ (CIS) who did not respond to BCG. Delivered directly into the bladder, Adstiladrin introduces a gene called interferon alpha-2b, which activates immune cells to target and kill cancer cells. This local approach minimizes side effects outside of the bladder, although some patients may experience bladder irritation. For some, Adstiladrin can be effective in reducing or eliminating cancer that remains after BCG treatment.

Anktiva (Nogapendekin Alfa Inbakicept-pmln)

Anktiva is an immunotherapy that enhances the immune response against bladder cancer by activating a protein called interleukin-15. It’s approved for patients with CIS who didn’t respond to BCG and is used together with BCG to boost its effectiveness. Delivered through a catheter into the bladder, Anktiva can help reduce cancer in some patients, though results vary. Side effects are usually limited to the bladder, including irritation.

BCG, Adstiladrin, and Anktiva all work to stimulate the immune system to fight cancer cells in the bladder. This is different from other immunotherapies like checkpoint inhibitors, which block pathways cancer cells use to hide from the immune system. Each therapy has its own side effects and benefits, so it is important to talk with your doctor about which might work best for your type of cancer and treatment plan.

Other Intravesical Therapies

Chemotherapy (chemo) drugs can be put right into the bladder through a catheter. These drugs kill actively growing cancer cells. Intravesical chemotherapy is most often used when intravesical immunotherapy with BCG doesn’t work. Giving chemo right into the bladder instead of injecting it into the bloodstream means these medicines that can kill cancer, usually do not reach and effect other parts of the body. This helps people avoid many of the side common effects that a person who receives systemic chemotherapy might experience. Here are some types of chemotherapy that can be put directly into the bladder.

Gemcitabine

Gemcitabine is a medicine that can help stop bladder tumors from coming back after surgery (TURBT). It is usually well tolerated, meaning most people don’t have serious side effects. Some people may have minor problems, like needing to urinate more often. When taken with another medicine known as oral alkalization (a method to help balance acidity), it causes very few side effects like nausea, vomiting, hair loss, or low blood counts.

INLEXZO™

INLEXZO is a small device that a doctor places inside your bladder using a catheter through your peeing tube. The device slowly releases a chemotherapy medicine called gemcitabine over about 3 weeks-which is how long this small device stays in the bladder where the cancer was located.  This means the medicine stays in your bladder longer to fight the cancer cells, while lowering the amount that goes to the rest of your body. INLEXZO is an option for some people whose cancer did not get better with BCG and who cannot, or choose not to, have surgery to remove the bladder.

Mitomycin C

Mitomycin C is another medicine used after TURBT that can help reduce the chance of bladder tumors returning by up to 50%. One good thing about Mitomycin C is that it does not easily enter the bloodstream, which makes it less risky than chemotherapy given through an IV. Some side effects can include pain when urinating or irritation of the bladder lining, which can feel like a urinary tract infection. These side effects are temporary and will go away once the treatment stops.

ZUSDURI is a treatment for people with low-grade, intermediate-risk bladder cancer that has come back but has not spread into the bladder wall. The medicine goes into the bladder as a liquid through a thin tube (catheter). Once inside, it warms to body temperature and becomes a gel. The gel slowly releases the cancer medicine (mitomycin) for about 5 hours, sometimes up to 24 hours, and then leaves the body when you urinate. This chemotherapy is put into the bladder once a week for 6 weeks for patients with low grade recurrent NMIBC. You go home the same day after treatment. It is done in an office setting without any surgery or anesthesia. It is very important to follow your doctor’s instructions and avoid having urine touching your skin for at least 24 hours. Common side effects include pain or burning when you pee, bladder infection, blood in the urine, and changes in blood tests.

Gemcitabine with Docetaxel

Gemcitabine with Docetaxel treatment combines gemcitabine with another medicine called docetaxel, and both are given directly into the bladder in a series of visits to the doctor’s office after TURBT. The side effects are similar to those of gemcitabine alone, and during the visit, one drug is given, drained out of the bladder, and then the second drug is administered.

Valrubicin

Valrubicin may also be given to some patients, especially if their carcinoma in situ (CIS) bladder cancer has not responded to BCG treatment and they cannot have surgery right away to remove the bladder.

Questions for Your Doctor

Discuss with your doctor which intravesical therapy might suit your situation, how long treatment might last, and what side effects to monitor.