Updates to UC and NMIBC Bladder Cancer Treatment

Last updated: January 2022

In 2021, the U.S. Food and Drug Administration (FDA) made decisions on several new treatments for bladder cancer. This may help provide more options for people with bladder cancer.1-3

Types of bladder cancer

When the FDA approves a treatment, the approval is specific to a certain type of bladder cancer. These new treatments are all intended for urothelial carcinoma (UC). One treatment was intended for a type of UC called non-muscle-invasive bladder cancer (NMIBC).1-3

UC is the most common type of bladder cancer in the United States. UC happens when cancer forms in the type of cell that lines the bladder. These are called urothelial cells. The lining is called the urothelium. When enough cancer cells grow, it can form a tumor in the urothelium.4

NMIBC is a type of UC. This diagnosis means the cancer has not spread from the urothelium into the wall of the bladder. The walls of the bladder are made of muscle, which is why NMIBC is called "non-muscle-invasive."5

Opdivo® (nivolumab) for UC

In August 2021, the FDA approved a drug called Opdivo® (nivolumab) for treating UC. Opdivo is made by Bristol-Myers Squibb. Before this, Opdivo had been given accelerated approval for only a small, specific group of people with UC. It was then only approved for cancer that had started to spread locally (advanced cancer) or around the body (metastatic cancer). Also, the people must have been treated with a certain type of chemotherapy in order to take Opdivo. Opdivo has also previously been approved to treat other types of cancer.1

This new decision now approves Opdivo for people with UC who have had surgery to remove their cancer and are at a high-risk of the cancer returning (recurrence). Opdivo works by using the T-cells that are part of our immune systems. Opdivo helps the T-cells find and identify cancer cells, which allows them to attack them.1

Vicineum™ (oportuzumab monatox-qqrs) for NMIBC

Vicineum™ (oportuzumab monatox-qqrs) is a drug made by Sesen Bio. Sesen Bio tried to get FDA approval for Vicineum as a treatment for NMIBC. Specifically, it was intended to be a treatment for bacillus Calmette-Guérin (BCG) unresponsive NMIBC.2

The FDA decided to not approve Vicineum in August 2021. However, the FDA did give recommendations on data it would like to see on Vicineum to consider approving it. Sesen Bio is planning on meeting with the FDA to find the best way forward for the approval of Vicineum.2

Keytruda® (pembrolizumab) for UC

The FDA approved Keytruda® (pembrolizumab) for people with advanced or metastatic UC in late August 2021. The new decision expands the approval of Keytruda to people who cannot receive a certain type of chemotherapy. This chemotherapy is called platinum-containing chemotherapy. Because this chemotherapy is not a good option for everyone, Keytruda may provide other options for treatment.3

Keytruda has previously been approved to treat people with UC but only in certain scenarios. This decision expands the number of people who are eligible for Keytruda. Keytruda works by helping the body’s immune system better identify and fight cancer cells. Keytruda is also approved for several other types of cancer.3

Bladder cancer treatment

These new decisions by the FDA may provide more options for people with bladder cancer. Even drugs like Vicineum, which was not approved at this time, may still be approved in the future.2

Having many options is important when treating any type of cancer. This is because all cancer does not respond the same way. Some treatments may work the first time. But other people will need to try different options until they find a treatment their cancer responds to. These new treatments will help provide extra opportunities for people fighting bladder cancer.1-3

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