AstraZeneca's Imfinzi Plus Imjudo Recommended for Approval in the EU
December 19 2022 - 2:55AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Monday that its Imfinzi and Imjudo
combinations have been recommended for marketing authorization in
the European Union for advanced liver and lung cancer.
The Anglo-Swedish pharma giant said the Committee for Medicinal
Products for Human Use of the European Medicines Agency based its
opinion on results from the Himalaya Phase 3 trial, and results
from the Poseidon Phase 3 trial.
The company said concurrent positive opinions recommend
authorizing Imfinzi in combination with Imjudo for first-line
treatment of adult patients with advanced or unresectable
hepatocellular carcinoma, or HCC. It also recommends Imfinzi in
combination with Imjudo and platinum-based chemotherapy for the
treatment of adult patients with Stage IV--metastatic--non-small
cell lung cancer.
The company said Imjudo plus Imfinzi was approved in the U.S. in
October for the treatment of adults with unresectable HCC, and that
in November Imjudo plus Imfinzi in combination with platinum-based
chemotherapy was approved in the U.S. for the treatment of adults
with metastatic non-small cell lung cancer.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
December 19, 2022 02:40 ET (07:40 GMT)
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