FDA approves AstraZeneca's Calquence for adult patients with mantle cell lymphoma

Accelerated approval of Bruton tyrosine kinase inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers.

Calquence is approved under the FDA's accelerated approval pathway, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Pascal Soriot, CEO of AstraZeneca, said: "The accelerated approval of Calquence is a landmark moment for our company. It provides an exciting new treatment option for patients with MCL and marks the first approval of a medicine that will be the cornerstone of our presence in hematology. Furthermore, today's approval demonstrates our commitment to scientific leadership in oncology and reinforces our progress towards returning to growth."

Michael L. Wang, MD, Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, and Principal Investigator of the ACE-LY-004 MCL clinical trial, said: "The acalabrutinib approval represents an important development for patients currently battling MCL, an aggressive type of blood cancer that is typically diagnosed at an advanced stage and associated with a high relapse rate. In addition to the overall response rate, the high complete response rate of 40% seen in this trial illustrates the potential of acalabrutinib to help patients."