Astrazeneca (AZN) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval for Calquence, in combination with bendamustine and rituximab, as a treatment for adult patients with previously untreated mantle cell lymphoma.
The company said the recommendation was based on the results of a phase 3 trial, where the combination therapy demonstrated over 16 months of progression-free survival improvement compared with chemoimmunotherapy alone.
Astrazeneca also said no new safety signals were identified during the trial, and Calquence's safety and tolerability remained consistent with its known safety profile.
The company is currently evaluating Calquence as a single treatment and in combination with standard-of-care chemoimmunotherapy for the treatment of multiple B-cell blood cancers, according to the statement.
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