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FDA Approves AstraZeneca’s Calquence (Acalabrutinib) in Combination With Bendamustine and Rituximab for Adult Patients With Previously Untreated Mantle Cell Lymphoma

January 17, 2025 10:37 AM | Katy Monaco

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.

The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review. It was based on results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress.

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