AstraZeneca’s Calquence Moves Closer to EU Approval for MCL Treatment

AstraZeneca’s Calquence (acalabrutinib), in combination with bendamustine and rituximab, has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This endorsement supports approval in the EU for treating previously untreated mantle cell lymphoma (MCL) in adults ineligible for stem cell transplantation. The recommendation is based on Phase III ECHO trial results, which demonstrated that the Calquence combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy. Patients receiving the combination experienced a median progression-free survival of 66.4 months, significantly longer than the 49.6 months observed with chemoimmunotherapy alone.

The CHMP’s decision marks an important step toward making Calquence the first BTK inhibitor approved for first-line MCL treatment in Europe. Dr. Martin Dreyling, a key investigator in the trial, emphasized the treatment's efficacy and tolerability, particularly for older patients. AstraZeneca’s Susan Galbraith highlighted Calquence’s potential to reshape the MCL treatment landscape, offering patients nearly 18 months of additional progression-free survival. Already approved in the US and other regions, Calquence is also under regulatory review in Japan and multiple other countries. If officially approved in the EU, it could significantly enhance outcomes for MCL patients, a group often diagnosed at advanced stages of this rare and aggressive cancer.