Bladder Cancer Vaccines

Bladder Cancer Vaccines

The U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Canadia, and the United Kingdom NHS say bacille Calmette-Guerin  (BCG) vaccination has shown positive results against types of bladder cancer, such as nonmuscle-invasive bladder cancer (NMIBC). In the 1970s, the BCG vaccine was approved as an immunotherapeutic treatment for bladder cancer patients. Since then, BCG has been the standard therapy for treating high-risk NMIBC patients to avoid the recurrence and progression of the disease.

With intravesical therapy for Bladder Cancer, a liquid drug (BCG) is inserted into your bladder through a tube (urinary catheter rather than giving it by mouth or injecting it into your blood, says Cancer.org. Drugs administered directly into the bladder affect the cells lining the inside of the bladder and have little to no effect on cells elsewhere. This means that intravesical therapy doesn't treat cancer cells outside the bladder lining, including those that have grown deeply into the bladder wall.

An abstract presented at the European Association of Urology 2022 Annual Meeting reported BCG vaccination nearly halved the risk of progression among patients with NMIBC compared with transurethral resection of the bladder, but only among those at high risk.

A report published in February 2023 estimates that more than 8,300 patients a year are not receiving full BCG treatments for their bladder cancer. Notably, 20% of the organizations reported being unable to provide BCG to patients eligible for therapy.

Bladder Cancer Vaccine Availability

Manufacturing changes in the production of BCG vaccines have resulted in worldwide shortages. Therefore, BCG constraints have had a clinical impact on Bladder Cancer treatment. Because of this situation, NMIBC patients might have received fewer doses of BCG than those recommended, might have received instillations of different BCG substrains depending on the BCG availability in each region, might have received a reduced length of standard maintenance therapy, and so forth. 

On July 24, 2023, the BCG vaccine manufactured by the Serum Institute of India began to be exported to Canada for immunotherapy to treat bladder cancer.

In Australia, intravesical immunotherapy BCG is approved.

Bladder Cancer Vaccine Candidates

ImmunityBio's Anktiva™ N-803 Plus BCG vaccine is a therapy to treat adults with NMIBC carcinoma in situ with or without Ta/T1 papillary disease.

Bladder Cancer Treatments

On November 30, 2023, Astellas Pharma Inc. and Seagen Inc. announced that the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. On December 15, 2023, Reuters reported  Astellas Pharma's Padcev, in combination with Keytruda, was approved for a type of bladder cancer.