The FDA has approved AstraZeneca’s Calquence (acalabrutinib), for adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Combined with venetoclax (brand name Venclexta, Abbvie/Genentech), it is the U.S.’ first all-oral, fixed-duration regimen for CLL and SLL.

In a press release, AstraZeneca said that results from a Phase III trial (AMPLIFY) informed the FDA’s decision. These results were presented at the American Society of Hematology 2024 and published in The New England Journal of Medicine.

New Option for Leukemia, Lymphoma Treatment

The results also have led to regulatory applications that are currently under review in multiple countries. Prior to the U.S., Calquence, a Bruton tyrosine kinase (BTK) inhibitor, was approved in the UK, European Union, and Canada.

Specifically, the results showed 77% of patients treated with acalabrutinib plus venetoclax were progression-free at three years. This contrasts with 67% progression-free following treatment with standard-of-care chemotherapy—either fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab.

Overall, AstraZeneca’s acalabrutinib formulation (plus venetoclax) reduced the risk of disease progression or death by 35% compared with chemoimmunotherapy.

Jennifer Brown, MD, PhD, who is the principal investigator of the AMPLIFY trial, said the duration of the treatment is 14 months. Brown is the Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute. She is also the Director of the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School.

AstraZeneca Applauds FDA Approval

Regarding CLL, it is the most common type of leukemia in adults. In the U.S., an estimated 18,500 people were treated in the first-line setting in 2024.

Dave Fredrickson, AstraZeneca Executive Vice President, Oncology Hematology Business Unit, said the approval underscores a commitment to improving the standard-of-care.

“This Calquence combination has the potential to meaningfully change first-line chronic lymphocytic leukemia treatment decisions,” Frederickson said.

AstraZeneca said no new safety signals were identified in the AMPLIFY trial. The safety and tolerability of Calquence was consistent with its known safety profile.