▎WuXiEdited by Kant Content Team

AstraZeneca announced today that its Bruton's tyrosine kinase (BTK) inhibitorCalquence (acalabrutinib) has been approved by the U.S. FDA for use in combination with bendamustine and rituximab for the treatment of previously untreated adult patients with mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation.The press release pointed out that this isThe U.S. FDA approved the first BTK inhibitor for frontline treatment of MCL.

The FDA's approval this time is based on the results of the Phase 3 clinical trial ECHO, and the study data was presented at the 2024 European Hematology Association (EHA) Congress. The data shows,Compared with standard chemoinfusion therapy, the Calquence combination therapy reduced the risk of disease progression or death by 27% (HR=0.73; 95% CI: 0.57-0.94; p=0.016). The median progression-free survival (PFS) was 66.4 months for patients treated with Calquence combination therapy and 49.6 months for those treated with chemoinfusion therapy.The safety and tolerability of Calquence are consistent with its known safety profile, and no new safety signals were identified.

MCL is a rare and aggressive non-Hodgkin lymphoma (NHL) caused by the transformation of B lymphocytes into malignant cells within the lymph node region known as the mantle zone. This disease is often diagnosed at an advanced stage and remains largely incurable.

Calquence is a BTK inhibitor developed by AstraZeneca. It can covalently bind to BTK and inhibit its activity.

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