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A person's hand holds a vial of medicine, which fades away into the darkness.

Tecentriq and Imfinzi Withdrawn as Bladder Cancer Treatments

The makers of TecentriqⓇ (atezolizumab) and ImfinziⓇ (durvalumab) have announced that they are voluntarily withdrawing both drugs as bladder cancer treatments in the United States.1,2

In 2016, the U.S. Food and Drug Administration (FDA) approved Tecentriq as a treatment for adults with metastatic bladder cancer that had been previously treated with chemotherapy. Tecentriq is made by the drug company Roche.1

In 2017, the FDA approved Imfinzi as a treatment for adults with locally advanced or metastatic bladder cancer. Imfinzi is made by the drug company AstraZeneca.1

What are Tecentriq and Imfinzi?

Both Tecentriq and Imfinzi belong to a class of drugs known as immunotherapies. These are drugs that use the body’s own immune system to fight cancer.1,2

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The immune system can work to fight cancer cells. However, some tumors can limit this by releasing a special protein called PD-L1. PD-L1 interferes with the immune system and keeps it from killing cancer cells. Tecentriq and Imfinzi work by binding to the PD-L1 protein found on cancer cells. This prevents the tumors from interfering with the immune system and makes it easier for the immune system to find and attack tumors.1-3

The FDA granted Tecentriq accelerated approval for bladder cancer treatment in 2016. This approval was based on the results from a clinical trial. The initial trial studied 310 people with bladder cancer. This trial found that 14.8 percent of people in the trial had their tumors shrink or disappear after taking Tecentriq.4

The FDA granted Imfinzi accelerated approval for bladder cancer treatment in 2017. This approval was based on results from a clinical trial. The initial trial studied 182 people with bladder cancer whose cancer had not responded to chemotherapy. This trial found that 17 percent of people in the trial had their tumors shrink or disappear after taking Imfinzi. The FDA may give accelerated approval to new drugs that treat a health condition with few or no other treatments.5

Why were Tecentriq and Imfinzi withdrawn?

Tecentriq and Imfinzi only received accelerated approvals from the FDA. This means that continued approval of each drug was dependent on more clinical results.

However, both drugs failed to deliver positive follow-up data from new studies required by the FDA. Because of this, Tecentriq and Imfinzi did not meet the additional requirements from the FDA for continued approval. Roche and AstraZeneca made separate decisions to withdraw the drugs as bladder cancer treatments.1,2,5,6

The withdrawals of Tecentriq and Imfinzi were not based on any safety concerns.1,6

What comes next?

Tecentriq is still approved for treating certain types of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), liver cancer, and skin cancer in the United States. It is also still approved to treat bladder cancer in some other countries.7

Imfinzi is still approved for treating certain types of NSCLC and small cell lung cancer SCLC in the United States and other countries. It is also still approved to treat bladder cancer in some other countries.2

Doctors have been informed of these new changes. If you have bladder cancer and are being treated with Tecentriq or Imfinzi, contact your doctor. Your doctor will be able to make recommendations for your future care.1,2

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