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BeiGene announces FDA acceptance and priority review of supplemental NDA for Brukinsa in marginal zone lymphoma.
BeiGene, Ltd. announced that the FDA has accepted a supplemental new drug application (sNDA) for Brukinsa (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review.
BeiGene, Ltd. announced that the FDA has accepted a supplemental new drug application (sNDA) for Brukinsa (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review.
The Prescription Drug User Fee Act (PDUFA) target action date is September 19, 2021. Clinical data in the sNDA submission include results from the single-arm, open-label, multicenter, Phase II MAGNOLIA trial (NCT03846427) in patients with relapsed or refractory (R/R) MZL as presented at the American Society of Hematology (ASH) Annual Meeting in December 2020, with supportive data from a global Phase 1/II trial (NCT02343120) in patients with B-cell malignancies. The submission also includes pooled safety data from 847 patients with B-cell malignancies treated with Brukinsa in seven clinical trials.
Condition: Marginal Cell Lymphoma
Type: drug
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