Shots:

• The approval is based on the P-III ASPEN trial to evaluate Brukinsa vs ibrutinib in patients with WM who have received 1 prior therapy or were unsuitable for chemo-immunotherapy
• The results showed a combined rate of CR & VGPR in an overall ITT population (28% vs 19%), a favorable safety profile with lower frequency of adverse reactions, patient discontinuation due to AEs (4%) & trial fails to meet 1EPs of deep response or VGPR & showed clinical benefit
• Brukinsa is being evaluated globally in a broad clinical program as monothx. & in combination with other therapies for multiple B-cell malignancies. The approval is available to all 27 EU member states along with Iceland & Norway

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Ref: Businesswire | Image: BeiGene