AstraZeneca's Imfinzi Wins FDA Priority Review to Treat Limited-Stage Small Cell Lung Cancer

By Adam L. Cataldo

AstraZeneca's cancer drug Imfinzi will get a priority review by the Food and Drug Administration for treating certain patients with limited-stage small cell lung cancer.

The priority review follows positive results from a Phase 3 trial for Imfinzi in patients with the aggressive form of lung cancer that hasn't progressed after receiving platinum-based concurrent chemoradiotherapy, AstraZeneca said on Thursday. Imfinzi reduced the risk of death by 27% versus placebo in the trial.

The FDA is expected to make a decision on approval in the fourth quarter.

Small cell lung cancer is a highly aggressive form of the disease that typically recurs and progresses rapidly despite an initial response to chemotherapy and radiotherapy, AstraZeneca said. The prognosis for patients with the disease is considered "particularly poor" with a survival rate of 15% to 30% five years after diagnosis.

Imfinzi also recently received a breakthrough therapy designation from the drug regulator for this form of lung cancer, the company said.

Priority review is given for medicines that, if approved, would offer significant improvements compared with already available options, the company said. A breakthrough therapy designation accelerates the development and regulatory review of potential new medicines that treat serious conditions and address a significant unmet medical need.

Imfinzi is approved to treat multiple types of cancer as a monotherapy as well as in combination with other drugs. Since its first approval in May 2017, more than 220,000 patients have been treated with Imfinzi, the company said.

Write to Adam Cataldo at adam.cataldo@wsj.com.

(END) Dow Jones Newswires

August 15, 2024 10:48 ET (14:48 GMT)

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