HQ Team
April 1, 2025: AstraZeneca’s drug to treat adult patients with previously untreated mantle cell lymphoma has been recommended for European Union approval.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion for the Calquence (acalabrutinib) drug, according to a statement.
The drug is used in combination with bendamustine and rituximab for the treatment of adult cancer patients with the disease who are not eligible for autologous hematopoietic stem cell transplantation.
Trial results
Results from the end-stage trials showed the combination drug reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median progression-free survival was 66.4 months for patients treated with the drug combination versus 49.6 with chemoimmunotherapy alone.
The EU medical body’s recommendation “is an important advance within the mantle cell lymphoma first-line treatment landscape, especially for older patients who need a balance of efficacy and tolerability,” said Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial.
‘First-line treatment’
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said the “positive recommendation from the CHMP further reinforces the potential of Calquence to advance first-line treatment options in mantle cell lymphoma,” with the drug combination demonstrating an almost one and a half year improvement in progression-free survival in this setting.
Mantle cell lymphoma is a rare and typically aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage. It is estimated that there are more than 21,000 patients diagnosed with MCL in the US, UK, France, Germany, Spain, Italy, Japan and China.
The drug combination is approved in the US and several other countries. Regulatory applications are currently under review in Japan.
Lymph nodes
Non-Hodgkin lymphoma is a type of cancer that affects the lymphatic system and is made up of organs, glands, tubelike vessels and clusters of cells called lymph nodes.
It’s part of the body’s germ-fighting immune system. Non-Hodgkin lymphoma happens when germ-fighting cells in the lymphatic system grow out of control. The cells can form growths, called tumours, throughout the body.
