Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Tuesday that it has received European Commission approval for Calquence (acalabrutinib) in combination with bendamustine and rituximab as a first-line treatment for adult patients with mantle cell lymphoma (MCL) ineligible for autologous stem cell transplant. This marks Calquence as the first and only Bruton's tyrosine kinase (BTK) inhibitor authorised in the EU for this setting.

The decision follows results from the ECHO Phase III trial, which demonstrated that the Calquence combination significantly extended median progression-free survival (PFS) by over 16 months compared to standard chemoimmunotherapy alone--66.4 months versus 49.6 months--reducing the risk of disease progression or death by 27% (HR 0.73; p=0.016).

MCL, a rare and aggressive form of non-Hodgkin lymphoma, often presents at an advanced stage. In 2024, approximately 6,000 new MCL cases were recorded across the UK, France, Germany, Spain and Italy. The safety profile of Calquence in the trial remained consistent with existing data and raised no new concerns.

The ECHO trial enrolled 635 patients aged 65 or older across 27 countries from 2017 to 2023 and included COVID-19 adjusted analyses. Calquence is already approved for first-line and relapsed MCL in several markets including the US, and regulatory reviews are ongoing in Japan and other countries.

Calquence, a selective second-generation BTK inhibitor, is also approved globally for chronic lymphocytic leukaemia and small lymphocytic lymphoma. AstraZeneca is currently expanding its haematology and oncology portfolios through development programmes and recent acquisitions, including Alexion and Gracell Biotechnologies, to address malignant and rare blood disorders.