07:18 AM EDT, 10/03/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Thursday that its supplemental new drug application for Calquence, or acalabrutinib, was accepted and granted priority review by the US Food and Drug Administration for the treatment of adults with previously untreated mantle cell lymphoma.

The company said it expects the FDA to act on the application in Q1 of 2025.

Results from a phase 3 trial showed that Calquence, in combination with bendamustine and rituximab, reduced the risk of disease progression or death by 27% compared to the standard-of-care chemoimmunotherapy, according to AstraZeneca ( AZN ).

In the trial, the median progression-free survival for patients treated with the Calquence combination was 66.4 months, almost 1.5 years longer than the 49.6 months observed in patients on standard therapy, the company said.

Additionally, overall survival showed "a favorable trend," although AstraZeneca ( AZN ) said the overall survival data were not mature enough at the time of analysis and the trial will continue to assess overall survival as a key secondary endpoint.

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