Artyom Smirnov, Co-Founder at Symptóme, shared a post on LinkedIn:
“FDA has approved Calquence (acalabrutinib) from AstraZeneca for adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
When combined with Venclexta (venetoclax) from AbbVie / Genentech, this becomes the first all-oral, fixed-duration regimen in the U.S. for CLL/SLL.
The Data Behind the Approval
The FDA decision was based on the Phase III AMPLIFY trial results, presented at American Society of Hematology 2024 and published in The New England Journal of Medicine.
Key outcomes:
77% progression-free at 3 years with acalabrutinib + venetoclax vs 67% with standard chemoimmunotherapy
35% reduction in risk of disease progression or death compared with chemoimmunotherapy
Fixed treatment duration: 14 months
No new safety signals were observed.
Global Context
Calquence was already approved in the UK, EU and Canada.
Regulatory reviews are ongoing in multiple countries.
Why This Matters
CLL is the most common adult leukaemia, with ~18,500 first-line patients treated in the U.S. in 2024.
An all-oral, time-limited option:
- Reduces reliance on chemotherapy
- Simplifies treatment logistics
- Potentially reshapes first-line decision-making.”