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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Tuesday, January 21, 2025
On January 16, 2025, the U.S. Food and Drug Administration (FDA) granted traditional approval to the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence) with bendamustine and rituximab (BR) for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). Traditional approval was also granted to acalabrutinib as a single agent for adults with previously treated MCL.
Efficacy was evaluated in the ECHO trial (ClinicalTrials.gov identifier NCT02972840), a randomized, double-blind, placebo-controlled, multicenter study of 598 patients with untreated MCL who were aged 65 or older and did not intend to receive HSCT. Patients were randomly assigned (1:1) to receive acalabrutinib plus BR or placebo plus BR.
Efficacy was based on progression-free survival, as assessed by an independent review committee. With a median follow-up of 49.8 months, progression-free survival was statistically significantly longer in the acalabrutinib arm (hazard ratio = 0.73; 95% confidence interval [CI] = 0.57–0.94; P = .016). The median progression-free survival was 66.4 months (95% CI = 55.1 months to not estimable) with acalabrutinib plus BR and 49.6 months (95% CI = 36.0–64.1 months) with placebo plus BR.
Serious adverse reactions occurred in 69% of patients given acalabrutinib plus BR, and fatal adverse reactions occurred in 12%. Serious adverse reactions reported in at least 2% of patients were pneumonia, COVID-19 infection, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia.
The recommended acalabrutinib dose is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity.
For full prescribing information for acalabrutinib, visit accessdata.fda.gov.
U.S. Food and Drug Administration
