FDA Approves Imfinizi to Reduce NSCLC Progression


Treatment with durvalumab (Imfinzi) reduces the risk of disease progression among patients with non-small cell lung cancer.

The FDA recently approved durvalumab (Imfinzi) for the treatment of patients with stage 3 non-small cell lung cancer (NSCLC) whose tumors are unresectable and whose disease has not progressed following treatment with chemoradiation, according to a press release.

This application was previously granted priority review and breakthrough therapy designations.

“This is the first treatment approved for stage 3 unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research.

Lung cancer is a leading cause of death in the United States and a majority of diagnoses are the NSCLC subtype. Stage 3 NSCLC is characterized by metastases in the lymph nodes or other nearby parts of the body.

Durvalumab is a checkpoint inhibitor that works by blocking the PD-1/PD-L1 pathways, which is thought to bolster the body’s defense against cancer, according to the FDA.

The new approval was based on positive findings from a clinical trial including 713 patients with NSCLC whose disease had not progressed following chemoradiation. The study evaluated progression-free survival (PFS) for durvalumab versus placebo.

The researchers found that the median PFS for patients taking durvalumab was 16.8 months compared with only 5.6 months for those taking placebo, according to the release.

Common adverse events associated with durvalumab in patients with NSCLC include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.

The FDA warns that durvalumab comes with serious risks. These risks include immune-mediated adverse events, in which the immune system attacks cells or organs, such as the lungs, liver, colon, hormone-producing glands, and kidneys. Other serious risks include infection and infusion-related reactions, according to the release.

In 2017, durvalumab was granted accelerated approval by the FDA for the treatment of patients with advanced or metastatic bladder cancer.

“For patients with stage 3 lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress,” Dr Pazdur said. “Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”

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