The European Commission (EC) has approved AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib), plus bendamustine and rituximab, to treat adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous stem cell transplant.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use and was supported by the ECHO Phase III trial outcomes.
Calquence with bendamustine and rituximab minimised disease progression or mortality risk by 27% against standard chemoimmunotherapy.
The median progression-free survival (PFS) was 66.4 months for subjects treated with the combination versus 49.6 months for those receiving only chemoimmunotherapy.
The tolerability and safety profile of Calquence was consistent with previous findings, with no safety signals observed.
AstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson stated: “Treatment with the Calquence combination in first-line mantle cell lymphoma demonstrated a significant improvement in progression-free survival 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."
Calquence's combination therapy has gained approval in countries including the US, with regulatory applications under review in Japan and elsewhere.
This current approval expands the treatment's global reach, following its recent EU approval as a single agent for treating adults with relapsed or refractory MCL.
Calquence is also approved for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in Japan, China and the US, and for CLL in the EU and many other countries.
AstraZeneca's Calquence is part of a comprehensive clinical development programme in which it is being explored as a monotherapy and in conjunction with standard chemoimmunotherapy for B-cell blood cancers, including MCL, diffuse large B-cell lymphoma and CLL.
In April 2025, the EC approved the company’s Imfinzi plus chemotherapy for the treatment of resectable non-small cell lung cancer (NSCLC) in adults.
