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

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For immediate release, Nov 21. 2019

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

On November 21, 2019, the FDA announced that it had approved the use of acalabrutinib (CALQUENCE, AstraZeneca) for the treatment of CLL/SLL.

Through Project Orbis, an international collaborative that includes the Australian Therapeutic Goods Administration (TGA), Health Canada and the FDA, there was simultaneous approval of the drug for CLL/SLL in Australia, Canada and the U.S.

The CLL Society’s Chief Medical Officer, Dr. Brian Koffman, shares his thoughts on today’s news. “This is a good day for CLL patients. It’s good to have more options, especially when the new option is a novel “non-chemo” oral medication, a second highly efficacious BTK inhibitor approved for use at any point in the CLL journey. The innovative Project Orbis that allowed approval in three countries on the same day is also to be commended. And of course, we owe a big debt of thanks to all the patients who entered the trials, without whom there would be no new drug approvals.”

For the official FDA news release that details the trials that lead to the approval and outlines the approval process itself, click here.

For more about Project Orbis, click here.

The CLL Society Inc. is a patient–centric, physician–curated nonprofit organization focused on patient education, support, and research, and dedicated to meeting the unmet needs of the CLL community.

For more media related information or questions, please contact us at media@CLLSociety.org.