AstraZeneca (AZN) said Friday that the US Food and Drug Administration has approved its experimental drug, calquence, combined with bendamustine and rituximab, for the treatment of certain adult patients with previously untreated mantle cell lymphoma.
The company said the approval was based on phase III results that showed calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
The drugmaker also said the approval converts calquence's earlier accelerated approval, granted by the FDA in October 2017, into full approval for adult mantle cell lymphoma patients.
AZN shares were 0.3% higher in recent premarket activity.
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