FDA Approves New Immunotherapy Drug for Bladder Cancer

The U.S. Food and Drug Administration (FDA) gave accelerated approval to immunotherapy drug Tecentriq (atezolizumab) this week for advanced bladder cancer. It is the first new drug approval in 3 decades for the disease, which is expected to be diagnosed in about 77,000 people in the U.S. in 2016.

Tecentriq is part of a new class of immunotherapy drugs called checkpoint inhibitors. This drug, given as an infusion, targets the PD-L1 protein, which some cancer cells use to evade the immune system. By blocking PD-L1, it helps immune cells recognize and attack cancer cells.

In a clinical trial that led to the drug’s approval, tumors shrank in 14.8% of participants with locally advanced or metastatic bladder cancer who had already received chemotherapy. The effect lasted from more than 2.1 months to more than 13.8 months. Among patients with higher levels of the PD-L1 protein on their cancer cells, 26% had a positive response to the treatment. Common side effects included fatigue, nausea, loss of appetite, fever, constipation, and urinary tract infections, but rarer and more serious side effects are possible.

The new approval is based on Tecentriq’s ability to shrink bladder tumors, but it is not yet clear if it can help people live longer.

Tecentriq is the second checkpoint inhibitor to be approved by the FDA this week. The drug Opdivo (nivolumab), already on the market for advanced melanoma, lung, and kidney cancers, was granted accelerated approval for some people with hard-to-treat classic Hodgkin lymphoma.

Tecentriq is the second form of immunotherapy approved for bladder cancer. The first was Bacillus Calmette-Guerin (BCG), a type of bacteria that is given directly into the bladder, which has been a mainstay treatment for early bladder cancer since the 1980s.

Tecentriq is marketed by Genentech.

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