New treatment approval for CLL

The European Medicines Agency has approved acalabrutinib for chronic lymphocytic leukaemia (CLL).

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The European Medicines Agency (EMA) has recommended that a new drug called acalabrutinib should be approved for the treatment of chronic lymphocytic leukaemia (CLL).

Acalabrutinib is a type of targeted drug called a cell signal blocker. It blocks a protein called ‘BTK’ on B cells. BTK is part of a pathway that helps B cells to stay alive and divide. Blocking BTK can make B cells die or prevent them dividing.

Large clinical trials have shown that acalabrutinib significantly improves the length of time people with CLL live without disease progression compared with other commonly used treatments. The EMA has recommended that it is granted a licence:

  • on its own or in combination with obinutuzumab (an antibody therapy) for adults with CLL who have not had treatment before
  • on its own for adults with CLL that has come back (relapsed) or not responded (refractory) after at least one previous course of treatment.

Acalabrutinib is given as a capsule that you take by mouth every day unless your lymphoma gets worse or you develop troublesome side effects.

Acalabrutinib 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.

4 August 2020