AstraZeneca announced FDA approval of Calquence (acalabrutinib) in combination with venetoclax as a treatment for adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma on February 20th, 2026. According to a company press release, it is the first oral, fixed-duration regimen treatment for these indications.

Approval was based on results from the AMPLIFY Phase III clinical trial, which found that 77% of patients treated with acalabrutinib plus venetoclax were progression-free at three years versus 67% of patients treated with standard-of-care chemotherapy. At 42.6 months, median progression-free survival was not reached for patients given acalabrutinib plus venetoclax versus 47.6 months for chemoimmunotherapy. Additionally, patients given acalabrutinib plus venetoclax demonstrated a 35% reduced risk of disease progression or death compared to chemoimmunotherapy, according to the release.

Acalabrutinib is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK) that is designed to prevent activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Venetoclax, marketed as Venclexta by Genentech, selectively binds to and inhibits the B-cell lymphoma-2 (BCL) protein. The build-up of BCL can prevent apoptosis, a process by which cancer cells die or self-destruct, according to a press release issued by Genentech.

“Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, in the AstraZeneca release. “This Calquence combination has the potential to meaningfully change 1st-line chronic lymphocytic leukaemia treatment decisions and underscores our commitment to improving on the current standard of care for people living with blood cancers.”

“Today’s approval represents an important step forward for people newly diagnosed with chronic lymphocytic leukemia,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, Genentech, in the Genentech release. “As the first and only all-oral, fixed-duration regimen, this approval gives patients the opportunity to spend more time off therapy. This milestone underscores the ongoing evolution of Venclexta-based approaches, offering clinicians another way to individualize first-line care.”