FDA Approves Imfinzi (Durvalumab) for Bladder Cancer

The US Food and Drug Administration (FDA) has approved the immunotherapy drug Imfinzi (durvalumab) to treat people with advanced urothelial carcinoma, the most common type of bladder cancer. The new drug is approved for use in people who have already had chemotherapy.

Imfinzi is part of a new class of immunotherapy drugs called checkpoint inhibitors. It’s the third checkpoint inhibitor to be approved for bladder cancer. 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.

The FDA also approved a test to check for levels of the PD-L1 protein.

In a clinical trial that led to the drug’s approval, tumors shrank in 17% of participants with locally advanced or metastatic bladder cancer who had already received chemotherapy. Among patients with higher levels of the PD-L1 protein on their cancer cells, 26% had a positive response to the treatment, compared to responses in 4% of patients with lower levels of PD-L1. It’s not yet clear how long these responses will last, as the study is still ongoing.

Common side effects of this drug include fatigue, muscle and bone pain, constipation, nausea, loss of appetite, swelling in the feet and legs, and urinary tract infections, but rarer and more serious side effects are possible.

Imfinzi was evaluated using accelerated approval, breakthrough therapy designation, and priority review status – FDA programs designed to speed up the availability of drugs to treat serious diseases. As a condition of accelerated approval, the company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

Imfinzi is marketed by AstraZeneca.

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