New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma
Pharmacy Times
JUNE 27, 2025
Acalabrutinib had previously received approval in 2017 as a single agent for this same indication. Because of its aggressive nature, MCL is typically treated with combination chemotherapy at diagnosis. The recent application was granted both priority review and orphan drug designation.
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