e large B-cell lymphoma, and multiple myeloma. It is also being studied as a monotherapy and in combination trials for the treatment of solid tumors. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have completed.
CALQUENCE was granted Orphan Drug Designation for the treatment of adult patients with MCL in September 2015 and Breakthrough Therapy Designation in August 2017 by the US FDA for the treatment of adult patients with MCL who have received at least one prior therapy.
About Mantle Cell Lymphoma (MCL)
MCL is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.6,7,8,9 MCL accounts for approximately 3% of new NHL cases in the US, with approximately 3,300 new cases diagnosed each year.10,11 The median age at diagnosis is 68 years, with a 3:1 male predominance.7 While MCL patients initially respond to treatment, there is a high relapse rate.
About the ACE-LY-004 trial
ACE-LY-004 is a Phase II open-label, single-arm clinical trial in 124 adult patients with relapsed or refractory MCL. The trial showed that 80% (95% CI: 72, 87) of patients treated with CALQUENCE achieved an overall response; 40% (95% CI: 31, 49) achieved a complete response and 40% (95% CI: 32, 50) achieved a partial response, per 2014 Lugano classification as assessed by Independent Review Committee.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm |
