(Alliance News) - AstraZeneca PLC on Monday announced a new approval in Japan as well as positive trials results for cancer drug Calquence.
Calquence has been approved in Japan to treat adults with relapsed or refractory chronic lymphocytic leukaemia, including small lymphocytic lymphoma. This follows previous approvals in the US and the EU.
Chronic lymphocytic leukaemia, a type of blood cancer, is not normally curable, though can be controlled through treatment. It is the most common type of adult leukaemia globally, though is considered rare in Japan and east Asia.
Approval in Japan was based on drug maker Astra's phase 3 Ascend trial, where Calquence was found to redce risk of disease progression or death by 69%.
Dave Fredrickson, executive vice president of Astra's Oncology Business Unit, said: "Chronic lymphocytic leukaemia is less prevalent in Japan than other regions, yet patients remain in need of innovative treatment options. This approval of Calquence offers patients in Japan a new, chemo-free, tolerable treatment option with uncompromised efficacy and the potential to positively impact quality of life."
The FTSE 100-listed company also announced positive high-level results from its Elevate-RR phase 3 trial. Calquence met the primary endpoint and demonstrated non-inferior progression-free survival in adults with previously treated high-risk chronic lymphocytic leukaemia compared to another cancer drug, ibrutinib.
Moreover, the trial met a key secondary endpoint for safety, with patients treated with Calquence having "statistically significantly lower incidence of atrial fibrillation", an irregular heart rare that can increase stroke and heart failure risk, compared to patients treated with ibrutinib.
Calquence binds to Bruton's tyrosine kinase, or BTK, and inhibits its activity. Astra explained that in B-cells, a type of immune cell, "BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion."
Jose Baselga, executive vice president of Oncology R&D at Astra, said: "With over forty months of follow-up, today's results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy. The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence."
Shares in Astra were up 0.7% at 7,833.00 pence in London on Monday morning.
By Anna Farley; annafarley@alliancenews.com
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