Michael Wang, MD,
The novel BTK inhibitor acalabrutinib demonstrated an objective response rate (ORR) of 81% with a complete response (CR) rate of 40% for patients with refractory mantle cell lymphoma (MCL), according to findings from the phase II ACE-LY-004 trial presented at the 2017 ASH Annual Meeting.
In late October 2017, the FDA approved acalabrutinib for patients with MCL following at least 1 prior therapy. The approval arrived several months ahead of expectations under the Prescription Drug User Fee Act and followed a breakthrough therapy designation from the FDA for MCL. The phase III ACE-LY-308 clinical trial is currently evaluating acalabrutinib in combination with bendamustine and rituximab (BR) versus placebo plus BR for patients with untreated MCL.
Wang M, Rule S, Zinzani PL, et al. Efficacy and Safety of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma in the Phase 2 ACE-LY-004 Study. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta, Georgia. Abstract 155.
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