AstraZeneca’s Bruton tyrosine kinase inhibitor, Calquence, in combination with bendamustine and rituximab have been approved by the U.S. FDA for the first-line treatment of mantle cell lymphoma (MCL) in patients who are ineligible for autologous hematopoietic stem cell transplantation.
MCL is a rare and typically aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage. Calquence oral tablets will offer an effective therapy that can improve outcomes for patients early in the treatment process.
The new approval was granted based on results from the ECHO phase 3 trial which were presented at the European Hematology Association 2024 Congress. Results showed Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
This new approval also converts Calquence’s accelerated approval to a full approval for adult patients with MCL treated with at least one prior therapy, as granted by the FDA in October 2017. The drug also has FDA approvals for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma.