The FDA approved acalabrutinib (Calquence) in combination with venetoclax (Venclexta) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval is for patients in the first-line setting.
“The continuous regimens frequently used to treat chronic lymphocytic leukaemia 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,” said Jennifer Brown, MD, PhD, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the AMPLIFY trial, in a press release from AstraZeneca. The biopharmaceutical company manufacturers acalabrutinib.
The approval follows results based on the phase 3 AMPLIFY trial, which showed that this fixed-duration combination significantly improved progression-free survival compared to standard chemotherapy. Patients receiving the regimen lived longer without disease progression and had a lower death rate than those on traditional chemoimmunotherapy.
The FDA used its Assessment Aid program to expedite the review and granted the application orphan drug designation. For more information, see the full FDA announcement here.
