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BeiGene announced acceptance and priority review by Health Canada for Brukinsa (zanubrutinib) in Waldenstrom’s macroglobulinemia (WM)
09 Sep 2020
Brukinsa (Zanubrutinib; Bruton’s tyrosine kinase (BTK) inhibitor) – BeiGene
- Data for submission to Health Canada – Phase 3 randomized, open-label, multicenter ASPEN clinical trial; zanubrutinib versus Imbruvica in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM
- Zanubrutinib demonstrated more frequent very good partial response (VGPRs) (28.4% vs.19.2% in the overall population)), although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met
- It demonstrated advantages in safety and tolerability compared to Imbruvica including reduced risk for certain cardiovascular issues
BeiGene’s Brukinsa (zanubrutinib) for Waldenström’s macroglobulinemia gets priority review in Canada
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CI Scientists Remarks:
- Brukinsa is an orally active, small molecule, BTKi approved for:
- US – MCL (Nov’19)
- China – MCL, CLL/SLL (Jun’20)
- Brukinsa is being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies
- Imbruvica, is the only approved BTKi for WM. Although Brukinsa showed numerically higher VGPR rates, and improvements in safety and tolerability compared to Imbruvica, it failed to demonstrate statistically significant superiority in complete response (CR) or VGPR rates
- With numerically higher response rates and superior safety profile compared to Imbruvica, BeiGene is hoping to become the second drug on the market
- There is another head-to-head trial in CLL testing Brukinsa against Imbruvica with results due in Q1’21
- Beigene is exploring Brukinsa as mono and in combination in several B cell malignancies:
Indication | Stage of development |
MCL | Approved |
WM | Filed |
CLL/SLL | Phase 3 |
Marginal Zone Lymphoma (MZL) | Pivotal Phase 2 |
DLBCL | Phase 2 |
Undisclosed B cell malignancies | Phase 1b |
- Brukinsa is approved in US and China only
– Dr. Kowndinya, CI Scientists