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