EU Approves AstraZeneca’s Calquence Combo As First-Line Therapy For Mantle Cell Lymphoma

AstraZeneca has received European Union approval for Calquence (acalabrutinib) in combination with bendamustine and rituximab as a first-line treatment for adult patients with mantle cell lymphoma (MCL) who are ineligible for autologous stem cell transplant. This approval by the European Commission was based on positive results from the Phase III ECHO trial, which showed that the Calquence combination significantly reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy.

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “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."

The ECHO trial reported a median progression-free survival of 66.4 months in the Calquence group versus 49.6 months for those on standard treatment. The combination therapy maintained a safety profile consistent with prior Calquence data, and no new safety issues were observed. The data were presented at the 2024 European Haematology Association Congress and published in The Journal of Clinical Oncology.

Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial, said: “This approval provides a new first-line treatment option for patients in the EU with mantle cell lymphoma, an aggressive lymphoma with a dismal long-term outcome still today. With a progression-free survival improvement of more than 16 months for these patients, the acalabrutinib combination is a much-needed advance in this challenging disease.”

MCL is a rare and aggressive type of non-Hodgkin lymphoma, with roughly 6,000 new cases diagnosed across major EU markets in 2024. Calquence is already approved in the US and several other countries for this indication. Regulatory submissions for this regimen are currently under review in Japan and other global markets, following this latest EU approval, which builds on its earlier approval for relapsed or refractory MCL in the region.