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Association details:
Biomarker:No biomarker
Cancer:Marginal Zone Lymphoma
Drug:Brukinsa (zanubrutinib) (BTK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Title:

BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma

Published date:
11/02/2022
Excerpt:
BeiGene...a global biotechnology company, today announced that the European Commission (EC) has granted marketing authorization of BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The approval is applicable to all 27 member states of the European Union (EU), plus Iceland and Norway.
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with...Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
Evidence Level:
Sensitive: B - Late Trials
Title:

BeiGene Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for BRUKINSA (Zanubrutinib) in Marginal Zone Lymphoma

Published date:
05/19/2021
Excerpt:
BeiGene, Ltd...announced that the U.S. Food and Drug Administration (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.