07:17 AM EDT, 03/31/2025 (MT Newswires) -- 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 ( AZN ) 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.