AstraZeneca PLC on Thursday said its drug Calquence received its first approval in China, for adults with previously treated mantle cell lymphoma, a rare type of non-Hodgkin lymphoma.
The Cambridge-based pharmaceutical company said the approval by the National Medical Products Administration in China was based on two trials, one of which showed an 82% overall response rate, with a 35% complete response rate. The trial illustrated that Calquence reduced the risk of disease progression or death by 52% at 12 months.
Calquence is a selective inhibitor of Bruton’s tyrosine kinase. Calquence binds covalently to BTK, thereby inhibiting its activity. In B cells, BTK signals results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
AstraZeneca shares were 0.5% lower at 10,928.00 pence each in London on Thursday morning.
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