The Investor
20 Feb 2026, 17:09
AstraZeneca’s Calquence combo wins US approval as first fixed-duration, all-oral frontline CLL regimen
AstraZeneca has received US Food and Drug Administration approval for Calquence (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration treatment for adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The approval is based on results from the Phase III AMPLIFY trial, which showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared with standard chemoimmunotherapy. At three years, 77% of patients treated with the Calquence plus venetoclax combination remained progression free, versus 67% in the chemotherapy arm. The regimen reduced the risk of disease progression or death by 35% (hazard ratio 0.65; p=0.0038), with median PFS not yet reached compared to 47.6 months for chemoimmunotherapy.
The combination is administered for a fixed duration of 14 cycles (approximately 14 months), offering an alternative to continuous treatment approaches that can carry cumulative side effects. Safety findings were consistent with the known profile of Calquence, with no new safety signals identified.
CLL is the most common adult leukaemia, with an estimated 18,500 patients treated in the first-line setting in the US in 2024. The newly approved regimen is positioned to reshape frontline treatment decisions by providing a time-limited, chemotherapy-free option.
Calquence plus venetoclax is already approved in the EU, UK and Canada, with additional regulatory reviews ongoing globally.
AstraZeneca has received US Food and Drug Administration approval for Calquence (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration treatment for adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The approval is based on results from the Phase III AMPLIFY trial, which showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared with standard chemoimmunotherapy. At three years, 77% of patients treated with the Calquence plus venetoclax combination remained progression free, versus 67% in the chemotherapy arm. The regimen reduced the risk of disease progression or death by 35% (hazard ratio 0.65; p=0.0038), with median PFS not yet reached compared to 47.6 months for chemoimmunotherapy.
The combination is administered for a fixed duration of 14 cycles (approximately 14 months), offering an alternative to continuous treatment approaches that can carry cumulative side effects. Safety findings were consistent with the known profile of Calquence, with no new safety signals identified.
CLL is the most common adult leukaemia, with an estimated 18,500 patients treated in the first-line setting in the US in 2024. The newly approved regimen is positioned to reshape frontline treatment decisions by providing a time-limited, chemotherapy-free option.
Calquence plus venetoclax is already approved in the EU, UK and Canada, with additional regulatory reviews ongoing globally.