AstraZeneca and Acerta Pharma, its hematology research and development center of excellence, have presented new, long-term follow-up results for CALQUENCE in patients with relapsed or refractory mantle cell lymphoma and updated results of an ongoing clinical trial assessing acalabrutinib monotherapy in treatment-naive patients with chronic lymphocytic leukemia at the 60th American Society of Hematology Annual Meeting & Exposition in San Diego, CA. Long-term follow-up data presented from the Phase II ACE-LY-004 trial in relapsed or refractory MCL showed sustained and clinically meaningful responses to CALQUENCE with a median follow-up of more than two years, confirming its efficacy and safety profile in this patient population. Initial data from this trial served as the basis for the accelerated approval of CALQUENCE for the treatment of adult patients with MCL who have received at least one prior therapy by the US Food and Drug Administration in October 2017. The ORR in the trial was 81%.
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