Drug Approval | December 20, 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers
Positive opinions based on significant survival benefit
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
While overall survival data remain immature, the results pointed to a favourable trend.
Across more than 85 abstracts, AstraZeneca will showcase 10 approved medicines and 13 potential new therapies
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
The new data highlight the potential of AstraZeneca’s innovative therapies to improve outcomes across multiple cancer types
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