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AstraZeneca’s BTK Inhibitor Acalabrutinib Approved in the EU for First-Line Treatment of Mantle Cell Lymphoma

May 06, 2025 14:40 CST Updated 14:40
AstraZeneca

Biopharmaceutical Manufacturer

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Local time on May 6, AstraZeneca announced,AcalabrutinibIn combination with bendamustine and rituximab, it has been approved in the EU for the treatment ofUntreated and ineligible for autologous stem cell transplantation mantle cell lymphoma（MCL）Adult patients. The press release noted that this is the EUThe First and OnlyA BTK inhibitor approved for this indication.
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Screenshot source: Corporate official website
This approval is based on the Phase III clinical trialPositive results of ECHO. This is aRandomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Aimed to EvaluateEfficacy and Safety of Acalabrutinib in Combination with Bendamustine and Rituximab versus SoC Chemoimmunotherapy(Bendamustine and Rituximab)Compare, for the treatment of adult MCL patients aged 65 years and above who have not received prior treatment.The primary endpoint is PFS.
The trial demonstrated that,Compared with standard chemotherapy immunotherapy,Acalabrutinib Combined with Bendamustine and Rituximab Therapy CanReduced the risk of disease progression or death by 27%(HR=0.73). AcceptPatients treated with acalabrutinib in combinationMedian Progression-Free Survival (PFS) For 66.4 months, while the median PFS for patients receiving chemotherapy immunotherapy alone was 49.6 months.
The safety and tolerability of acalabrutinib were consistent with its known safety profile, and no new safety signals were identified.
It is worth mentioning that,According to the results of the ECHO,Acalabrutinib Combined with Bendamustine and Rituximab TherapyAlready in the United States(January 17, Year 25)Approved for MCLFirst-line TreatmentCurrently, Japan and several other countries are reviewing the registration application for this indication.
Acalabrutinib is a second-generation BTK selective inhibitor.As part of a broad clinical development program,Acalabrutinib is currently being used as a monotherapy or in combination with standard chemoimmunotherapy regimens to treat various patients with B-cell blood cancers, includingCLL, MCL, and Diffuse Large B-Cell Lymphoma。
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