Drug Approval | June 17, 2024
Imfinzi approved in the US for endometrial cancer
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
Longest survival follow-up ever reported for immunotherapy treatment in this setting
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial
About 75% of all primary liver cancers in adults are HCC and up to 30% of HCC patients are eligible for embolisation
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Positive opinions based on significant survival benefit
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
These results will be presented on 21 January at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium
The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib
The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting
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