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EMA Recommends Extension of Indications for Acalabrutinib to Include the Treatment for Patients with MCL

New indication concerns the treatment of patients with relapsed or refractory mantle cell lymphoma
03 Apr 2025
Targeted Therapy
Lymphomas

On 27 February 2025, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product acalabrutinib (Calquence).

The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted a new indication to include treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

The full indications for Calquence will therefore be as follows (new indication in bold):

  • Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
  • Calquence as monotherapy is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory MCL not previously treated with a BTK inhibitor.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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