Calquence, AstraZeneca’s BTK Inhibitor Approved by FDA

Therapeutic for patients with previously treated mantle cell lymphoma wins accelerated approval.

With 80% of patients experiencing an overall response with Calquence® (acalabrutinib) and 40% achieving a complete response in clinical trials, the FDA granted accelerated approval to AstraZeneca’s Bruton tyrosine kinase (BTK) inhibitor on October 31st.

Pascal Soriot, AstraZeneca’s Chief Executive Officer said: "The accelerated approval of CALQUENCE is 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."

Principal Investigator in the ACE-LY-004 MCL clinical trial, Michael L. Wang, a Professor, with the University of Texas MD Anderson Cancer Center’s Department of Lymphoma/Myeloma, added to this, saying: "The acalabrutinib approval 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 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."

Lymphoma Research Foundation CEO Meghan Gutierrez further summarized this achievement noting "Relapse is common in mantle cell lymphoma patients and represents disease progression. When patients learn there is a new treatment option available for their disease, it brings great hope and an opportunity to participate in shared decision making with their healthcare team."


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