First BTK inhibitor to show favourable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
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
Application based on results from the TROPION-Breast01 Phase III trial
Combination shows consistent benefit across prespecified post-progression outcomes
To accelerate the development of next-generation radioconjugates to treat cancer
The validations confirm the completion of the applications and commence the scientific review process
About 75% of all primary liver cancers in adults are HCC and up to 30% of HCC patients are eligible for embolisation
Submission to be reviewed under FDA real-time oncology review and Project Orbis
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