AstraZeneca's Imfinzi Plus Chemotherapy Recommended for Market Authorization in EU
14 Noviembre 2022 - 01:49AM
Noticias Dow Jones
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)
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