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Zanubrutinib (Brukinsa TM) has an FDA accelerated approval and an EMA/EC marketing authorization for relapsed/refractory Marginal Zone B-Cell Lymphomas / Marginal Zone Lymphomas (MZLs) in adults after at least one anti‑CD20‑based regimen. Basis is overall response rate and duration of response from two open‑label, multicenter, single‑arm trials, including phase II MAGNOLIA study (1, 2, 3)
(1) [the-u-s-food-and-drug-administration-approves-zanubrutinib-for-marginal-z…