Reports from FDA and AstraZeneca's safety updates

AstraZeneca's Calquence Plus Bendamustine and Rituximab Approved by FDA for First-Line MCL Treatment, Achieving 66.4 Months PFS

Jan 17, 2025, 08:13 PM

AstraZeneca Plc has received U.S. Food and Drug Administration (FDA) approval for its drug Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval, based on the results of the phase 3 ECHO trial, marks Calquence as the first Bruton's tyrosine kinase (BTK) inhibitor approved for first-line treatment of MCL in the U.S. The trial demonstrated a significant improvement in progression-free survival, with patients receiving the Calquence combination experiencing a median progression-free survival of 66.4 months compared to 49.6 months with standard chemoimmunotherapy alone. The Calquence combination reduced the risk of disease progression or death by 27%, and when censored for COVID-19 deaths, this risk reduction increased to 36%. Although overall survival data were not mature at the time of analysis, a favorable trend was observed. The safety profile showed serious adverse events in 69% of patients, with no new safety signals identified. Additionally, the FDA has converted the accelerated approval of Calquence as a monotherapy for previously treated MCL to full approval.