Drug Approval
FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
- By IPP Bureau
| February 23, 2026
The US FDA has approved AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration treatment for adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years, compared with 67% for standard chemoimmunotherapy. Median progression-free survival (PFS) was not reached for the oral regimen versus 47.6 months for chemotherapy, reducing the risk of disease progression or death by 35%.
“The continuous regimens frequently used to treat chronic lymphocytic leukaemia often come with side effects that may become burdensome to patients over time,” said Jennifer Brown, Director of the CLL Center at Dana-Farber Cancer Institute and principal investigator of AMPLIFY.
“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.”
Dave Fredrickson, Executive Vice President of the Oncology Haematology Business Unit at AstraZeneca, added: “Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia. 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.”
Gwen Nichols, Chief Medical Officer of Blood Cancer United, formerly The Leukemia & Lymphoma Society, commented: “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.”
