India Pharma Outlook Team | Monday, 20 January 2025
AstraZeneca's Calquence (acalabrutinib), combined with bendamustine and rituximab, has received approval in the US for treating adult patients with previously untreated mantle cell lymphoma (MCL) who cannot undergo autologous hematopoietic stem cell transplantation.
The Food and Drug Administration (FDA) granted approval following the acquisition of Priority Review. The findings originated from the ECHO phase III clinical trial that was showcased at the European Haematology Association 2024 Congress.
MCL is an uncommon and usually aggressive type of non-Hodgkin lymphoma (NHL), frequently identified at an advanced stage. It is estimated that over 21,000 individuals have been diagnosed with MCL in the US, UK, France, Germany, Spain, Italy, Japan, and China.
Michael Wang, MD, Puddin Clarke Endowed Professor, director of Mantle Cell Lymphoma Programme of Excellence and principal investigator in the trial, said: "Managing this aggressive cancer requires maximising efficacy while maintaining tolerability, especially for elderly patients. Results from the pivotal ECHO trial highlight the promise of the acalabrutinib combination in defining a new standard of care, with today’s approval underscoring the transformative potential of this regimen as a first-line treatment for older patients with mantle cell lymphoma."
, CDSCO.jpg)
