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Dr. Henry Fung discusses the efficacy and safety of CALQUENCE® (acalabrutinib), including 24-month update analysis data from the Phase II ACE LY-004 trial.
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CALQUENCE is indicated for the treatment of adults with previously treated mantle cell lymphoma (MCL). This indication is approved under accelerated approval; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Serious adverse events, including fatal events, have occurred with CALQUENCE, including serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, and atrial fibrillation and flutter. The most common adverse reactions (≥ 20%) of any grade in patients with relapsed or refractory MCL were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising.
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