TRENTON, N.J. — U.S. regulators have approved a new drug that harnesses the immune system to treat bladder cancer that has spread after chemotherapy or surgery.
The Food and Drug Administration on Monday approved Imfinzi for advanced bladder cancer, along with a companion diagnostic test for identifying which patients are most likely to benefit from it.
Imfinzi, also known as durvalumab, is part of a new generation of drugs that stimulate the immune system to help fight cancer. British drugmaker AstraZeneca PLC, which developed the drug, is testing it for several other cancers.
The average monthly list price for Imfinzi is roughly $15,000, but varies with the patient's weight, according to AstraZeneca. It's given by IV, usually every two weeks.
Imfinizi works by binding to a protein, found in varying levels on
In a company-funded study, 26
The FDA gave the drug accelerated approval and is requiring AstraZeneca to complete ongoing testing in more patients to confirm the drug's benefits and safety.
Common side effects include fatigue, bone and muscle pain, nausea, swelling in hands and feet, and urinary tract infections. Infections elsewhere in the body were infrequent. However, two patients died, one from a lung infection and the other from a liver infection.
Bladder cancer is the sixth most common type of cancer in the U.S., with about 79,000 new cases and nearly 17,000 deaths expected this year, according to the National Cancer Institute. When bladder cancer has spread, only about 5
Until recently, treatment options were limited to chemotherapy, radiation or surgery.
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