News|Articles|February 20, 2026

FDA Approves Calquence in Combination with Venetoclax for Treatment of Adults with Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma

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Key Takeaways

FDA authorization establishes acalabrutinib–venetoclax as a chemotherapy-free, 14-month, fixed-duration first-line option for adult CLL/SLL and the first time-limited BTKi-based regimen in the US.
Phase III AMPLIFY demonstrated 3-year PFS of 77% with acalabrutinib–venetoclax versus 67% with FCR or BR, with median PFS not reached versus 47.6 months.
Risk of progression or death was reduced by 35% versus chemoimmunotherapy, supporting a shift away from indefinite continuous regimens for appropriately selected frontline patients.
Trial eligibility excluded del(17p) and TP53-mutated disease; randomization included acalabrutinib–venetoclax, the same doublet plus obinutuzumab, or standard chemoimmunotherapy with independent PFS review.
No new safety signals emerged, and tolerability was consistent with established acalabrutinib experience, reinforcing feasibility of an all-oral, time-limited approach.

FDA approves AstraZeneca’s fixed-duration, all-oral Calquence plus venetoclax regimen for first-line CLL and SLL in adults.

AstraZeneca announced FDA’s decision to approve its all-oral, fixed-duration combination of Calquence and venetoclax, positioning the regimen as the first Bruton’s tyrosine kinase inhibitor–based therapy in the country to offer a time-limited, chemotherapy-free option for previously untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma.

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The approval covers adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), the most common adult leukaemia.¹

Calquence plus venetoclax is already approved in the European Union, Canada and the United Kingdom, with additional regulatory reviews ongoing.²

Beyond CLL and SLL, Calquence is approved in multiple markets for mantle cell lymphoma and is being studied across a broader development program in B-cell malignancies, including diffuse large B-cell lymphoma.²

Jennifer Brown, MD, PhD, director of the CLL Center at the Dana-Farber Cancer Institute and principal investigator of Amplify, said the approval introduces a meaningful alternative to indefinite therapy.

“The continuous regimens frequently used to treat CLL often come with side effects that may become burdensome to patients over time. The US approval of the Calquence combination offers patients an all-oral, 14-month, fixed-duration treatment option that is highly effective and well-tolerated and gives physicians greater flexibility to tailor treatment plans for individual patient needs and goals.”

What is FDA’s approval of Calquence based on?

The approval is based on results from the Phase III Amplify trial, presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine.

In the U.S., an estimated 18,500 patients were treated in the first-line CLL setting in 2024 and while some individuals remain asymptomatic at diagnosis, others experience fatigue, infections, lymph node enlargement and other systemic symptoms as abnormal B lymphocytes accumulate in blood, bone marrow and lymphatic tissue.¹

Results from Amplify showed that 77% of patients treated with Calquence plus venetoclax were progression-free at three years, compared with 67% of patients receiving investigator’s choice of chemoimmunotherapy, either fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab.¹

Median progression-free survival was not reached in the combination arm versus 47.6 months in the chemotherapy group. The regimen reduced the risk of disease progression or death by 35% compared with chemoimmunotherapy.¹

Dave Fredrickson, executive vice president of the Oncology Haematology Business Unit at AstraZeneca, said the approval “delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia” and “has the potential to meaningfully change 1st-line chronic lymphocytic leukaemia treatment decisions.”

The trial enrolled patients without del(17p) or TP53 mutation across 27 countries between 2019 and 2021, continuing through the COVID-19 pandemic. Patients were randomized to receive fixed-duration Calquence plus venetoclax, the same combination with obinutuzumab, or standard chemoimmunotherapy. The primary endpoint was progression-free survival assessed by independent review.

Gwen Nichols, MD, chief medical officer of Blood Cancer United, formerly The Leukemia & Lymphoma Society, said fixed-duration options can alter the treatment experience for patients facing an incurable but often slowly progressing disease.

“Managing an incurable blood cancer that progresses slowly can often feel indefinite and overwhelming. We welcome new treatment options that may ease the burden, restore a sense of control and offer renewed hope for those navigating life with chronic lymphocytic leukaemia.”

Safety findings were consistent with the known profile of Calquence, and no new safety signals were identified.

Sources

Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting AstraZeneca Februrary 20, 2026 https://www.astrazeneca.com/media-centre/press-releases/2026/fixed-duration-calquence-combo-approved-in-us.html
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia AstraZeneca November 9, 2020 https://www.astrazeneca.com/media-centre/press-releases/2020/calquence-approved-in-the-eu-for-cll.html#

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