AstraZeneca’s Calquence approved by EC for first-line mantle cell lymphoma use
AstraZeneca (AZ) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) has been approved by the European Commission (EC) as part of a combination treatment for patients with mantle cell lymphoma (MCL).
The oral drug has been authorised for use alongside standard-of-care chemoimmunotherapy, bendamustine and rituximab, in adults with previously untreated MCL who are not eligible for autologous stem cell transplant.
MCL is a rare and typically aggressive form of non-Hodgkin lymphoma that is often diagnosed at an advanced stage and associated with a high relapse rate. An estimated 6,000 people in the UK, France, Germany, Spain and Italy were diagnosed with the disease in 2024.
Calquence, which is now the first in its drug class to be approved in the EU for first-line MCL use, is designed to inhibit the activity of the BTK protein that leads to the growth of abnormal cancerous B cells.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the phase 3 ECHO trial.
Calquence plus bendamustine and rituximab demonstrated a 27% reduction in the risk of disease progression or death compared to standard-of-care chemoimmunotherapy.
Median progression-free survival (PFS) was 66.4 months for patients randomised to receive the Calquence combination, compared to 49.6 months for those in the chemoimmunotherapy cohort, and the safety and tolerability of AZ’s drug was consistent with its known safety profile.
The approval comes less than four months after the US Food and Drug Administration approved the Calquence combination for the same indication.
Commenting on the latest authorisation for the drug, Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “Treatment with the Calquence combination in first-line MCL demonstrated a significant improvement in PFS and a consistent safety profile for patients in the pivotal ECHO trial. As the first and only BTK inhibitor approved in this indication in the EU, we are proud to provide a much-needed new option to patients living with this difficult disease.”
