The US Food and Drug Administration (FDA) has granted Priority Review status to the supplemental New Drug Application (sNDA) for acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

Acalabrutinib is currently indicated for the treatment of adult patients with MCL who have received at least one prior therapy, as well as for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA’s Priority Review acceptance was based on results from the ECHO phase III trial presented during the late-breaking oral session at the European Hematology Association (EHA) 2024 Hybrid Congress.

In the trial, acalabrutinib plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared with standard-of-care (SoC) chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). The addition of acalabrutinib to SoC provided almost 1.5 years of additional median progression free survival (mPFS) with mPFS of 66.4 months for patients treated with the acalabrutinib combination versus 49.6 months with SoC.

After censoring for COVID-19 deaths (the ECHO trial was conducted during the COVID-19 pandemic), the PFS was further improved, with the acalabrutinib combination reducing the risk of disease progression or death by 36% (HR 0.64; 95% CI; 0.48-0.84; P=0.0017).