By Joe Hoppe

 

AstraZeneca PLC said Monday that its Imfinzi product has been recommended for marketing authorization in the European Union for treating adults with biliary tract cancer, in combination with chemotherapy.

The Anglo-Swedish pharma major said that the European Medicines Agency based its positive opinion on results from the Topaz-1 Phase 3 trial.

The studies showed that the combination of Imfinzi and chemotherapy reduced the risk of death by 24% when compared to chemotherapy alone. Around 23.6% of patients were still alive after two years, compared with 11.5% of patients given chemotherapy alone.

The treatment is for unresectable or metastatic biliary tract cancer, a group of rare and aggressive cancers. It was generally well-tolerated by patients.

Imfinzi plus chemotherapy is already approved in the U.S., Canada, South Korea and Brazil for biliary tract cancer, and regulatory applications are under review in Japan and several other countries.

"The combination of [Imfinzi] and chemotherapy is a significant advance for patients after more than a decade of limited progress, and this regimen should become a new standard of care option once approved," said Juan Valle, a lead investigator in the trial and professor of medical oncology at the University of Manchester.

 

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

 

(END) Dow Jones Newswires

November 14, 2022 02:34 ET (07:34 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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