New York, NY (October 31, 2017) –The U.S. Food and Drug Administration (FDA) announced it has approved the use of acalabrutinib (CALQUENCE) to treat patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca, was granted priority review status by the FDA earlier this year and was approved under the FDA’s Accelerated Approval pathway.
“The approval of acalaburitinib (CALQUENCETM) marks an important advance for patients with relapsed mantle cell lymphoma and for those who have received at least one prior therapy,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “Clinical trials are crucial for identifying effective therapies for lymphoma patients, including those which led to this approval. Because mantle cell lymphoma is such a rare disease, clinical trials are critical and so the Foundation commends the patients, families, and scientists who enabled this research and advancement for patients.”
For more information on the FDA approval of acalabrutinib (CALQUENCETM), visit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm. For additional information on mantle cell lymphoma, visit www.focusonmcl.org.
About the Lymphoma Research Foundation
The Lymphoma Research Foundation (LRF) is the nation’s largest non-profit organization devoted to funding innovative research and serving the lymphoma community through a comprehensive series of education programs, outreach initiatives and patient services. To date, LRF has awarded nearly $60 million in lymphoma-specific research.
For additional information on LRF’s research, education and services, visit lymphoma.org.
Since January of 2005, the Lymphoma Research Foundation has been proud to convene the Mantle Cell Lymphoma Consortium (MCLC), which is comprised of more than 100 laboratory and clinical scientists from North America and Europe who focus their research on MCL. The MCLC is designed to accelerate the understanding and treatment of MCL by bringing together these lead investigators, funding innovative studies and creating resources. LRF’s Mantle Cell Lymphoma Consortium is one of the Foundation’s longest running scientific program, encouraging collaboration and the sharing of research developments between the world’s leading MCL researchers, including LRF MCL Consortium members, MCL grantees, and scientists from the United States, Canada, and Europe. Since its inception, the MCL Scientific Workshop has helped researchers make significant strides in understanding MCL biology, evaluating potential new therapies, and optimizing the use of currently available therapies. Next year’s MCL Scientific Workshop will be held from April 25-26, 2018 in Atlanta, Georgia. For more information on the MCL Consortium and Scientific Workshop, visit www.lymphoma.org/MCLWorkshop.