U.S. Food and Drug Administration Approves Acalabrutinib (CALQUENCE) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

On November 21, 2019, the U.S. Food and Drug Administration (FDA) announced it has approved the use of acalabrutinib (CALQUENCE, AstraZeneca) as a monotherapy for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

This approval expands the use of acalabrutinib, which received accelerated approval from the FDA for the treatment of adult patients with mantle cell lymphoma (MCL).

“The approval of acalabrutinib as a monotherapy represents a major advancement for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma,” said Lymphoma Research Foundation Chief Executive Officer, Meghan Gutierrez. “Novel therapies and new methods of administration are important to ensuring that patients and their physicians, through shared decision making, are able to access the right treatments at the right time.”

For more information on the FDA approval of acalabrutinib (CALQUENCE), visit the FDA’s website or lymphoma.org/CLLFDAUpdates.

Oral Therapies Learning Center

Currently, there are a number of chemotherapy and targeted anticancer drugs approved or under investigation for the treatment of lymphoma that can be taken by mouth, either in liquid or tablet/capsule form.  Oral agents are just as effective and can have similar side effects as anticancer drugs that are given intravenously. Learn more >