Acalabrutinib

AstraZeneca’s Calquence is being assessed as part of a comprehensive clinical development programme. Credit: © AstraZeneca 2025. 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. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “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.

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. “With a PFS improvement of more than 16 months for these patients, the [Calquence] combination is a much-needed advance in this challenging disease,” said trial investigator Martin Dreyling, University Hospital LMU Munich. 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.”