EU Approves AstraZeneca Mantle Cell Lymphoma Treatment

Mississauga, On, Canada - October 24, 2020: Astrazeneca Canada company sign is seen in Mississauga, Ontario, Canada. AstraZeneca plc is a British pharmaceutical and biopharmaceutical company. | Image Credit: © JHVEPhoto - stock.adobe.com

AstraZeneca announced on May 6, 2025 that its Calquence (acalabrutinib), a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK), was approved in the European Union in combination with bendamustine and rituximab for treatment of adults with mantle cell lymphoma (MCL) that has been previously untreated, and who are not eligible for an autologous stem cell transplant (1). Acalabrutinib had been previously approved in the EU as monotherapy for treatment of adults with relapsed or refractory MCL.

In a press release, AstraZeneca said the combination of acalabrutinib with bendamustine and rituximab was previously approved in the United States and other countries based on the results of a Phase III trial (ECHO), the findings of which were also used by the European Commission’s Committee for Medicinal Products for Human Use (CHMP) in its positive opinion issued March 31, 2025 (2).

“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,” Dave Fredrickson, executive vice president of the Oncology Haematology Business Unit for AstraZeneca, said in the release (1). “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."

Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial, added, saying “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.”

In February 2025, another MCL treatment, Eli Lilly and Company’s Jaypirca (pirtobrutinib)—a non-covalent or reversible BTK inhibitor—was given a positive opinion by CHMP (3,4). That treatment, according to Lilly, had been approved by FDA in 2023 under an accelerated approval pathway for treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and BCL-2 inhibitor, or for treatment of adults with relapsed or refractory MCL after at least two lines of systemic therapy.

Acalabrutinib treatment plus bendamustine and rituximab is currently under review in Japan and several other countries (1).

References

1. AstraZeneca. Calquence Plus Chemoimmunotherapy Approved in the EU as First and Only BTK Inhibitor for 1st-Line Mantle Cell Lymphoma. Press Release. May 6, 2025.
2. AstraZeneca. Calquence Plus Chemoimmunotherapy Recommended for Approval in the EU by CHMP as First and Only BTK Inhibitor for 1st-Line Mantle Cell Lymphoma. Press Release. March 31, 2025.
3. Eli Lilly and Company. Lilly's Jaypirca (pirtobrutinib) Recommended by CHMP for Approval in the European Union for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Previously Treated with a BTK Inhibitor. Press Release. Feb. 28, 2025.
4. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 February 2025. Press Release. Feb. 28, 2025.