EMA Recommends Extension of Indications for Zanubrutinib

On 15 September 2022, 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 zanubrutinib (Brukinsa).

The marketing authorisation holder for this medicinal product is BeiGene Ireland Ltd.

The CHMP adopted a new indication for the treatment of marginal zone lymphoma.

For information, the full indications for Brukinsa will therefore be as follows (new indication in bold):

BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.

BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available 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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