AstraZeneca Calquence approved in EU for treatment of adults with MCL

AstraZeneca’s (AZN) Calquence in combination with bendamustine and rituximab has been approved in the European Union, EU, for the treatment of adult patients with previously untreated mantle cell lymphoma, MCL, who are not eligible for autologous stem cell transplant. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from ECHO Phase III trial, presented at the European Haematology Association 2024 Congress and published in The Journal of Clinical Oncology, which demonstrated that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. Median progression-free survival was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.