Shots:
- The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regions
- Approval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutation
- Trial showed 77% (without Gazyva) & 83% (with Gazyva) vs 67% were progression-free at 3yrs. & a 35% & 58% reduction in risk of disease progression or death, respectively, with mPFS not reached for either treatment arms vs 47.6mos.; data was presented at ASH 2024 & published in The NEJM
Ref: Astrazeneca | Image: Astrazeneca| Press Release
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