Calquence - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

acalabrutinib

Opinion

On 27 March 2025, the 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 Calquence. The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted a new indication to include treatment of adults with previously untreated mantle cell lymphoma. The full indications for Calquence will therefore be as follows: ¹

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 chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), 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.

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¹ New text in bold.

CHMP post-authorisation summary of positive opinion for Calquence (II-25)

Reference Number: EMA/CHMP/103398/2025

Key facts

• Name of medicine:
  Calquence
• EMA product number:
  EMEA/H/C/005299
• Active substance:
  acalabrutinib
• International non-proprietary name (INN) or common name:
  acalabrutinib
• Therapeutic area (MeSH):
  Leukemia, Lymphocytic, Chronic, B-Cell
• Anatomical therapeutical chemical (ATC) code:
  L01EL02
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  AstraZeneca AB
• Date of opinion:
  27/03/2025
• Status:
  Positive