AstraZeneca PLC (LON:AZN) said the Japanese authorities have approved Calquence for chronic lymphocytic leukaemia (CLL) that has come back after a period of improvement or that is hard to treat.
The drug is a Bruton's tyrosine kinase inhibitor, meaning it prevents malignant B-cells from reproducing and decreases their survival.
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The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from a trial where the candidate showed a statistically significant and clinically meaningful improvement compared to the standard therapy.
CLL is the most common type of adult leukaemia across the globe but is considered a rare disease in Japan and East Asia, representing between 1% and 2% of patients diagnosed with leukaemia, the FTSE 100 group said.
"Chronic lymphocytic leukaemia is less prevalent in Japan than other regions, yet patients remain in need of innovative treatment options,” said the firm’s executive vice president of the oncology business unit, Dave Fredrickson, in a release.
“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."
Calquence vs ibrutinib
In a separate announcement, the pharma giant said Calquence met the main goal of a trial on adults with previously treated, high-risk CLL compared to ibrutinib, a current standard of care.
The trial also met a key secondary goal for safety, showing patients treated with the candidate had statistically significantly lower incidence of atrial fibrillation compared to patients treated with ibrutinib.
Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications.
Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and approved for CLL in the EU and several other countries worldwide.
Commenting on the latter update, analysts at Liberum said Calquence would have shown other benefits "in an ideal world" but there was no sacrifice on efficacy, which will be a good point of differentiation against ibrutinib.
This year ibrutinib, sold under the name of Imbruvica by AbbVie's Pharmacyclics and Janssen Biotech, will generate sales of over US$4bn, while Calquence is selling around US$500mln.
"These data should allow further share gains for Calquence," the broker noted.
Shares rose 1% to 7,842.51p early on Monday.
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