AstraZeneca Reports the US FDA’s sNDA Acceptance of Calquence with Priority Review for Mantle Cell Lymphoma
Shots:
- The US FDA has accepted & granted priority review to sNDA of Calquence for treatment-naïve adults with mantle cell lymphoma. The decision is expected during Q1’25
- Submission was based on P-III (ECHO) study assessing the safety & efficacy of Calquence + bendamustine & rituximab (SoC) vs SoC to treat MCL adults (n=635, over 65yrs.). Data was featured at EHA 2024
- The study showed a 27% reduction in the disease progression or death risk with an mPFS of 66.4mos. vs 49.6mos. and an immature OS with favorable trends (assessment continues). In the pre-specified analysis, carried out at the time of pandemic censoring COVID-19-related deaths, showed improved PFS of 36% across both arms & a favorable OS trend towards the regimen
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca Provides Update on P-III (AMPLIFY) Trial of Calquence for Treating Chronic Lymphocytic Leukemia
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
