"Acalabrutinib" approved for first-line treatment of mantle cell lymphoma.

On January 17th, Astrazeneca PLC Sponsored ADR (AZN.US) announced that the BTK inhibitor Calquence (acalabrutinib) has received FDA approval for a new indication, to be used in combination with bendamustine and rituximab for the treatment of mantle cell lymphoma (MCL) in adult patients who have not been previously treated and are not eligible for autologous stem cell transplantation. This drug is the first BTK inhibitor approved for first-line treatment of MCL. The FDA approval was primarily based on the positive results of the Phase III ECHO study. This study was a multi-center, randomized, double-blind, placebo-controlled clinical trial (n=635), evaluating the efficacy and safety of acalabrutinib in combination with standard of care treatment (bendamustine + rituximab) compared to standard of care treatment in previously untreated MCL adult patients aged 65 or older. The primary endpoint of the study was progression-free survival (PFS). The results showed that the PFS extension effect in MCL patients in the acalabrutinib group was superior to the standard of care group (66.4 vs 49.6 months, HR=0.73, P=0.0160), the data being statistically and clinically significant. Additionally, a positive trend towards an extension in overall survival (OS) was observed in MCL patients in the acalabrutinib group in this study (HR=0.86, P=0.27).