AstraZeneca's rare cancer drug Calquence gets US regulatory nod
By Benjamin Chiou
Date: Friday 17 Jan 2025
(Sharecast News) - AstraZeneca has announced that its Calquence drug has been approved in the US when used alongside chemoimmunotherapy for patients with previously untreated mantle cell lymphoma (MCL).
Calquence (otherwise known as acalabrutinib), is now the first and only BTK inhibitor - drugs which block activity of the Bruton's tyrosine kinase enzyme - approved for the first-line treatment of MCL in the country.
The approval by the Food and Drug Administration follows the results of the ECHO Phase III trial which showed more than 16 months of progression-free survival improvement versus chemoimmunotherapy alone.
MCL is a rare and aggressive form non-Hodgkin lymphoma (NHL), often diagnosed at an advanced stage, affecting an estimated 21,000 people across the US, UK, France, Germany, Spain, Italy, Japan and China.
"With today's approval, Calquence provides a critical new treatment option to mantle cell lymphoma patients in the US, with Calquence proven to deliver nearly one and a half years of additional time without disease progression," said Dave Fredrickson, executive VP of AstraZeneca's Oncology Haematology Business Unit.
"This approval brings a new and effective treatment option to those living with this disease and further reinforces our belief in Calquence as a backbone therapy across multiple blood cancers."
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