AstraZeneca and its hematology research and development unit Acerta Pharma, announced that the Food and Drug Administration (FDA) was granted accelerated approval toCalquence(acalabrutinib), a drug used to fight an aggressive form of blood cancer.
The OK in the U.S. is for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Calquenceis approved under the FDA’s accelerated approval process, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need. Continued approval may hinge on verification and description of clinical benefit in trials.
Pascal Soriot, CEO of AstraZeneca, said: “The accelerated approval ofCalquenceis a landmark moment for our company. It provides an exciting new treatment option for patients with mantle cell lymphoma 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.”
Shares of AstraZeneca have been on the rise, due in part to encouraging news in the cancer treatment arena. The company has an estimated 1,500 employees in Delaware who work in administration, with a smaller number at a distribution hub near Newark.
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 acalabrutinibapproval represents an important development for patients currently battling mantle cell lymphoma, an aggressive type of blood cancer that is typically diagnosed at an advanced stage and associated witha high relapse rate. In addition to the overall response rate, the high complete response rate of 40 percent seen in this trial illustrates the potential of acalabrutinibto help patients achieve a deep response.”