In its second late-stage trial success in a month, the drug showed
meaningful improvement in patients with chronic lymphocytic leukemia
when compared with a chemotherapy-based treatment, the company said.
The drug, Calquence, is a cornerstone product for AstraZeneca in
haematology and its accelerated U.S. approval in 2017 marked its
first entry into blood cancer treatment.
"The positive results from both the ... trials will serve as the
foundation for regulatory submissions later this year," said R&D
José Baselga, executive vice president of the company's oncology
division.
The drug, which is already approved by the U.S. drug regulator to
treat a rare type of blood cancer, met the primary endpoint in a
trial in May testing the drug in comparison with available
treatment.
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AstraZeneca acquired the drug, also known as acalabrutinib, when it
bought a majority stake in Acerta Pharma in 2015.
Calquence is currently approved for treating adults with relapsed or
refractory mantle cell lymphoma in the United States, Brazil, UAE
and Qatar, and is being developed for the treatment of chronic
lymphocytic leukemia and other blood cancers.
The company's shares were up 0.8% at 6005 pence in early trading on
the London Stock Exchange.
(Reporting by Sangameswaran S in Bengaluru; Editing by Saumyadeb
Chakrabarty
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