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Acalabrutinib receives CHMP positive opinion for the treatment of patients with chronic lymphocytic leukemia

Jul 29, 2020

On 23 July, 2020, acalabrutinib received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the granting of marketing authorisation for the treatment of adult patients with chronic lymphocytic leukemia (CLL). 1

Acalabrutinib, a next-generation selective inhibitor of Bruton’s tyrosine kinase (BTK), was approved in the US for the treatment of adult patients with CLL and for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 2

The positive opinion was based on the results from two randomised, multicenter, open-label, phase III clinical trials: 2

  • The ELEVATE TN trial ( NCT02475681 ), comparing acalabrutinib combined with obinutuzumab  vs acalabrutinib alone  vs standard chemo-immunotherapy treatment (chlorambucil plus obinutuzumab) in patients with treatment-naïve CLL. Results from this trial showed a decrease in the risk of disease progression or death by 90% and 80% in patients treated with acalabrutinib combined with obinutuzumab and patients treated with acalabrutinib alone, respectively, compared with standard chemo-immunotherapy treatment
  • The ASCEND trial ( NCT02970318 ), evaluating acalabrutinib vsinvestigator’s choice of either rituximab in combination with idelalisib, or rituximab in combination with bendamustine in patients with relapsed or refractory CLL. In this trial, 88% of patients in the acalabrutinib arm remained alive and free from disease progression after 12 months compared with 68% of patients in the investigator’s choice arm

The CHMP recommendation is for 1,2

  • acalabrutinib as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL
  • acalabrutinib as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy

  1. EMA. Calquence. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/calquence. Published Jul 24, 2020. Accessed Jul 28, 2020.
  2. AstraZeneca. Calquence recommended for approval in the EU by CHMP for chronic lymphocytic leukaemia. https://www.astrazeneca.com/media-centre/press-releases/2020/calquence-recommended-for-approval-in-the-eu-by-chmp-for-chronic-lymphocytic-leukaemia.html. Published Jul 27, 2020. Accessed Jul 28, 2020.