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Association details:

Biomarker:
No biomarker
Direction:
Sensitive

Evidence:

Evidence Level:
Sensitive: A1 - Approval
New
Title:
BeiGene Announces the Approval of BRUKINSA™ (Zanubrutinib) in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma
Published date:
06/03/2020
Excerpt:
BeiGene, Ltd....today announced that its BTK inhibitor BRUKINSA (zanubrutinib) has received approval from the China National Medical Products Administration (NMPA) in two indications – the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
12/03/2020
Excerpt:
Suggested treatment regimens...CLL/SLL without del(17p)/TP53 mutation…Second-line and subsequent therapy…other recommended regimens...Zanubrutinib (for patients with intolerance or contraindication to other BTKi)
Evidence Level:
Sensitive: B - Late Trials
Title:
BRUKINSA (Zanubrutinib) Demonstrates Superior Objective Response Rate by Investigator Assessment and Reduced Rates of Atrial Fibrillation or Flutter at Interim Analysis in Head-to-Head Trial Against Ibrutinib in Chronic Lymphocytic Leukemia
Published date:
04/28/2021
Excerpt:
BeiGene...announced positive results from a planned interim analysis of the Phase 3 ALPINE trial comparing BRUKINSA (zanubrutinib) against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)...BRUKINSA met the primary endpoint of the trial, demonstrating non-inferiority in objective response rate (ORR)...
Trial ID:
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