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MHRA (United Kingdom) approves Brukinsa for the treatment of adultswith Waldenström’s macroglobulinemia.

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Published:16th Dec 2021
BeiGene announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Brukinsa (zanubrutinib) in Great Britain, for the treatment of eligible adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of eligible patients unsuitable for chemo-immunotherapy.

Although the primary endpoint of statistical superiority related to deep response, very good partial response (VGPR) or better, was not met in the Phase III ASPEN trial, Brukinsa demonstrated a higher VGPR rate – 28% (29/102) compared to 19% in ibrutinib (19/99). In addition, 94% of patients on Brukinsa (n=102) continued to respond for a year or longer compared with 88% of patients on ibrutinib (n=99) who continued to respond for a year or longer. Additionally, compared to ibrutinib, Brukinsa demonstrated a lower frequency of certain adverse events, including atrial fibrillation or flutter (2/101, 2.0% vs. 15/98, 15.3%), minor bleeding (49/101, 48.5% vs. 58/98, 59.2%), and major haemorrhage (6/101, 5.9% vs. 9/98, 9.2%).

Condition: Waldenstrom's Macroglobulinemia
Type: drug

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