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AstraZeneca Reports Breakthrough Therapy Designation For Calquence - Quick Facts

AstraZeneca (AZN.L,AZN) said Calquence (acalabrutinib), a monotherapy treatment for adult patients with chronic lymphocytic leukaemia, has been granted Breakthrough Therapy Designation by the FDA. The FDA decision was based on the positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials.

Separately, AstraZeneca and Merck & Co. announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer. The trial showed a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab. The trial met its primary endpoint with a statistically-significant and clinically-meaningful improvement in progression-free survival.

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