21st Nov 2019 18:40
(Alliance News) - AstraZeneca PLC on Thursday said its drug Calquence has been approves in the US for adults patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma.
The approval by the US Food & Drug Administration results from positive analyses from two phase 3 clinical trials, Elevate-TN in patients with previously untreated CLL and Ascend in patients with relapsed or refractory CLL.
In Elevate-TN, Calquence combined with obinutuzumab and as a monotherapy reduced the risk of disease progression by 90% and the risk of death by 80%.
Dave Fredrickson, executive vice president of drug major Astra's Oncology Business Unit said: "With over 20,000 new cases anticipated this year in the US alone, today's approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment."
Shares in FTSE 100-listed Astra closed up 1.2% at 7,344.00 pence in London on Thursday.
By Anna Farley; [email protected]
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