AstraZeneca's (AZN.US) "Acalabrutinib" has been approved for the frontline treatment of mantle cell lymphoma.

On January 17, AstraZeneca (AZN.US) announced that its BTK inhibitor Calquence (acalabrutinib) has been approved by the FDA for a new indication, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have not received prior therapy and are ineligible for autologous hematopoietic stem cell transplantation. The drug is the first BTK inhibitor approved for the first-line treatment of MCL. The FDA's approval was mainly based on the positive results of the III phase ECHO study. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial (n=635) to evaluate the efficacy and safety of acalabrutinib in combination with standard treatment (SOC, i.e., bendamustine + rituximab) versus SOC alone in previously untreated adult patients aged 65 years or older with MCL. The primary endpoint was progression-free survival (PFS). The results showed that the PFS of MCL patients in the acalabrutinib group was significantly longer than that in the SOC group (66.4 vs 49.6 months, HR=0.73, P=0.0160), with statistical and clinical significance. In addition, a positive trend of prolonged overall survival (OS) was observed in MCL patients in the acalabrutinib group (HR=0.86, P=0.27) in this study.