FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting
The Genexus platform enables Next-Generation Sequencing with significantly faster turnaround times
Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
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