Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

The agency also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib received accelerated approval for this indication in 2017.

Efficacy was evaluated in ECHO (ClinicalTrials.gov Identifier: NCT02972840), a multicenter, randomized, double-blind, placebo-controlled trial in 598 patients with untreated MCL who were at least 65 years of age and not intended to receive HSCT. Patients were randomized (1:1) to receive acalabrutinib plus bendamustine and rituximab (BR) or placebo plus BR.

Efficacy was based on progression-free survival (PFS), as assessed by an independent review committee. With a median follow-up of 49.8 months, PFS was statistically significantly longer in the acalabrutinib plus BR arm (hazard ratio, 0.73; 95% CI, 0.57-0.94; P=0.016). The median PFS was 66.4 months (95% CI, 55.1 months to not estimable) in the acalabrutinib plus BR arm and 49.6 months (95% CI, 36.0-64.1 months) in the placebo plus BR arm.

Serious adverse reactions occurred in 69% of patients who received acalabrutinib plus BR, and fatal adverse reactions occurred in 12%. Serious adverse reactions reported in 2% or more of patients were pneumonia, COVID-19, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis and anemia.

The full prescribing information for Calquence is posted here.

Based on a press release from the FDA.