▎WuXiEdited by Kant Content Team

Today, AstraZeneca announced that the U.S. FDA has accepted and granted priority review for the supplemental New Drug Application (sNDA) for Calquence (acalabrutinib), a Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

This application is primarily based on the positive results of the Phase 3 clinical trial ECHO. Data recently presented at the European Hematology Association (EHA) annual meeting showed,Calquence in combination with bendamustine and rituximab reduced the risk of disease progression or death by 27% (HR=0.73, 95% CI: 0.57-0.94, p=0.016) in patients with MCL compared to standard chemoimmunotherapy. The median progression-free survival in the Calquence combination therapy group reached 66.4 months, which is nearly one and a half years longer than the 49.6 months observed in the standard treatment group.

In terms of overall survival, the combination therapy of Calquence showed a favorable trend compared with the standard treatment (HR=0.86, 95% CI: 0.65-1.13, p=0.2743). However, the overall survival data were not yet mature at the time of analysis, and the clinical trial will continue to evaluate this key secondary endpoint.

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

Calquence has received accelerated approval from the U.S. FDA for the treatment of adult patients with MCL who have received at least one prior therapy. It has also been approved for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

▲To learn more about the application of cutting-edge technologies in the biopharmaceutical industry, please long press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate support or opposition from WuXi AppTec regarding the views in the article. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media circles, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain the reprint guidelines.