LONDON (dpa-AFX) - British drug major AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that the European Union or EU has approved Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma or MCL who are not eligible for autologous stem cell transplant.
MCL is a rare and typically aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use or CHMP. It is the first and only BTK inhibitor approved in this indication in the EU, the company noted.
The approval follows the recent approval for Calquence monotherapy for the treatment of adult patients with relapsed or refractory MCL in the EU.
The company noted that the latest decision was based on positive results from ECHO Phase III trial, evaluating the efficacy and safety of Calquence plus bendamustine and rituximab compared to SoC chemoimmunotherapy in adult patients at or over 65 years of age with previously untreated MCL.
The trial results demonstrated that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. In the trial, median progression-free survival was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.
The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.
The trial results were presented at the European Haematology Association (EHA) 2024 Congress and published in The Journal of Clinical Oncology.
Martin Dreyling, investigator in the trial, said, 'This approval provides a new first-line treatment option for patients in the EU with mantle cell lymphoma, an aggressive lymphoma with a dismal long-term outcome still today. With a progression-free survival improvement of more than 16 months for these patients, the acalabrutinib combination is a much-needed advance in this challenging disease.'
Calquence plus bendamustine and rituximab is approved in the US and several other countries in this setting based on the ECHO results. In Japan and several other countries, regulatory applications are currently under review in this indication.
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