AZN AstraZeneca PLC

By Joe Hoppe

AstraZeneca PLC said Wednesday that a combination treatment of its Imfinzi drug and chemotherapy has been granted priority review status by U.S. federal health regulators for patients with locally advanced or metastatic biliary tract cancer.

The pharmaceutical major said its supplemental biologics license application, or sBLA, followed interim results from a placebo-controlled Phase 3 trial, which showed an improved overall survival rate with the combination treatment compared with standard chemotherapy alone.

The U.S. Food and Drug Administration grants priority review status to medicinal applications that, if approved, would offer significant improvements over available options.

Data from the Phase 3 trial showed the combination therapy reduced the risk of death by 20% compared with standard chemotherapy, and an estimated one in four patients treated were alive at the two-year mark, compared with one in 10 using chemotherapy alone, the company said.

The data also showed the combination had a statistically significant 25% reduction to the risk of disease progression or death, and was generally well tolerated, the company said.

"We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy," Susan Galbraith, AstraZeneca's executive vice president, oncology research and development, said.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

May 04, 2022 02:43 ET (06:43 GMT)

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