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Imfinzi approved by FDA as treatment to reduce NSCLC progression risk

The US Food and Drug Administration (FDA) has expanded the approval of Imfinzi (durvalumab) to provide a therapy to slow the progression of cancer in certain patients with non-small cell lung cancer (NSCLC). AstraZeneca first gained accelerated FDA approval for Imfinzi in May 2017.

Imfinzi is an antineoplastic monoclonal antibody indicated for the treatment of patients with metastatic urothelial carcinoma or unresectable NSCLC that has not progressed following chemoradiation. The latest approval from the FDA allows the drug to be used to treat patients with stage III NSCLC for whom tumor removal is not an option, but whose cancer has not progressed after chemotherapy and radiation.

“Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

He noted this is the first treatment to gain FDA approval to reduce the risk of cancer progressing in patients with stage III unresectable NCSLC. The FDA granted the application Priority Review and Breakthrough Therapy designations.

NCSLC is the most common form of lung cancer, accounting for between approximately eight of ten cases. There are several subtypes of NCSLC, the most prevalent of which is adenocarcinoma (four in ten cases), followed by squamous cell (epidermoid) carcinoma and large cell (undifferentiated carcinoma). Lung cancer is the second most common form of cancer in both men and women (excluding skin cancer), representing around 14 percent of all new cancer cases.

Approval for Imfinzi was granted on the back of a randomized trial of 713 patients, which measured the length of time tumors did not grow significantly in patients given Imfinzi or a placebo. The median progression-free survival for patients taking Imfinzi was 16.8 months, compared to just 5.6 months in those receiving a placebo.

Common Side Effects of Imfinzi

A cough


Inflammation in the lungs

Upper respiratory tract infections

Breathing difficulties


Serious risks associated with Imfinzi

Immune-mediated side effects (e.g. pneumonitis, hepatitis, colitis, nephritis or endocrinopathies)


Infusion-related reactions

Harm to developing fetuses

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