AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)
Shots:
- The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions
- Approval was based on P-III (ECHO) study of the combination vs chemoimmunotherapy alone (SoC) in previously untreated MCL adults (over 65yrs.; n=635)
- Trial depicted PFS of 27%, with mPFS of 66.4 vs 49.6mos. & improved PFS of 36% after censoring COVID-19 deaths; OS was immature but a favorable trend was observed, despite 69% of chemoimmunotherapy patients receiving BTK inhibitors upon relapse
Ref: AstraZeneca | Image: AstraZeneca
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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.
