FDA Approves Imfinzi (Durvalumab) for Some Lung Cancers

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for people with stage III (3) non-small cell lung cancer who are not able to be treated with surgery to remove their tumor, and whose cancer has not gotten worse after they received chemotherapy along with radiation (chemoradiation). The goal of treatment with this drug is to keep the cancer from getting worse for as long as possible.

Imfinzi is already on the market as a treatment for people with bladder cancer. It’s 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.

The new approval for Imfinzi was based on a randomized clinical trial of 713 people with stage III (3) non-small cell lung cancer whose cancer had not gotten worse after they completed chemoradiation, and whose tumors could not be removed through surgery. The goal of the trial was to measure progression-free survival, which is the length of time the tumors did not grow or spread. The people who received Imfinzi had an average progression-free survival of 16.8 months compared to 5.6 months for those in the trial who did not receive Imfinzi.

Earlier this year, Imfinzi was granted breakthrough therapy designation and priority review status – FDA programs designed to speed up the availability of drugs to treat serious diseases.

Common side effects of Imfinzi are cough, fatigue, inflammation in the lungs, upper respiratory tract infections, difficulty breathing, and rash. Serious risks can include immune-mediated reactions, where the body’s immune system attacks healthy cells or organs. Additional risks include infection and infusion-related reactions. Imfinzi can cause harm to a developing fetus if taken by a pregnant woman.

Imfinzi is marketed by AstraZeneca. 

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