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AstraZeneca's blood cancer drug Calquence gets US FDA breakthrough-therapy tag

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AstraZeneca's blood cancer drug Calquence gets US FDA breakthrough-therapy tag

AstraZeneca PLC said the U.S. Food and Drug Administration granted breakthrough-therapy designation to blood cancer medicine Calquence.

The U.K.-based company is developing Calquence as a single therapy for adults with chronic lymphocytic leukemia, or CLL, a condition in which the bone marrow produces too many abnormal white blood cells called lymphocytes while crowding out healthy white blood cells that fight infections.

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CLL is the most common type of leukemia in adults, with an estimated 191,000 new cases globally and 20,720 new cases in the U.S. annually.

The designation was based on results of late-stage studies Elevate-TN and Ascend, in which Calquence alone or in combination with other cancer therapies helped extend patients' lives without worsening their disease.

AstraZeneca plans to use the results of Elevate-TN and Ascend to seek regulatory approval later in 2019.

Calquence is approved to treat certain adults with mantle cell lymphoma, a rare form of blood cancer, in the U.S., Brazil, the United Arab Emirates and Qatar. The drug is being developed for treating CLL and other blood cancers, including diffuse large B-cell lymphoma and multiple myeloma.