Acalabrutinib (Calquence; AstraZeneca) with bendamustine and rituximab has been greenlit for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem-cell transplantation (HSCT). Officials with the FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL.1
Efficacy was evaluated in ECHO (NCT02972840), a double-blind, placebo-controlled, multicenter trial in 598 patients with untreated MCL who were aged ≥65 years and not intended to receive HSCT in which patients were randomly assigned to receive acalabrutinib plus bendamustine and rituximab (BR) or placebo plus BR.
With a median follow-up of 49.8 months, progression-free survival (PFS) was statistically significantly longer in the acalabrutinib arm (hazard ratio, 0.73; 95% confidence interval [CI], 0.57-0.94; P=.016). The median PFS was 66.4 months (95% CI, 55.1-not estimable) in the acalabrutinib plus BR arm and 49.6 months (95% CI, 36.0-64.1) in the placebo plus BR arm.
Serious adverse reactions occurred in 69% of patients with acalabrutinib plus BR, and fatal adverse reactions occurred in 12%. Serious adverse reactions reported in ≥2% of patients were pneumonia, COVID-19, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia.
Reference
- FDA. FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma. January 16, 2025. Accessed February 10, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma