New treatment approval for WM

The European Medicines Agency has approved zanubrutinib for Waldenström’s macroglobulinaemia (WM). 

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The European Medicines Agency (EMA) has recommended that a new drug called zanubrutinib should be approved for the treatment of Waldenström’s macroglobulinaemia (WM).

Zanubrutinib is a type of targeted drug called a BTK inhibitor. It blocks a protein called Bruton’s tyrosine kinase (BTK). BTK is part of a chemical signalling pathway that helps B cells (the cells that are affected by WM) to stay alive and divide. Blocking BTK can make the B cells die or stop them dividing.

Zanubrutinib is a capsule that you take by mouth twice a day. You carry on taking it unless your lymphoma gets worse or you develop side effects that are difficult to cope with.

In clinical trials, around 96% of people with WM responded to zanubrutinib treatment, with almost half experiencing a complete response or very good partial response. The most common side effects were low blood counts, respiratory infections, bleeding or bruising, rash, joint or muscle pain, and diarrhoea.

The EMA has recommended that it is granted a licence:

  • for adults with WM who have already had at least one previous course of treatment
  • as a first treatment for adults with WM who are not able to have chemo-immunotherapy.

Zanubrutinib is currently being assessed by the National Institute for Health and Care Excellence (NICE), to decide if it should be made available on the NHS. We will report on the outcome when it is announced.

Published: 4 November 2021