A decision from the US regulator is expected by the first quarter of 2025.
The sNDA for Calquence is being assessed by the FDA under Project Orbis, an initiative that enables concurrent filing and review of oncology therapies among international partners.
The application for Calquence is supported by results from the ECHO Phase III trial.
This randomised, double-blind, placebo-controlled, multi-centre study assessed the efficacy and safety of Calquence plus bendamustine and rituximab versus standard-of-care (SoC) chemoimmunotherapy in adult MCL patients aged 65 years or older.
According to the trial data, the combination of Calquence with bendamustine and rituximab offered a 27% reduction in the disease progression or mortality risk versus SoC chemoimmunotherapy.
Furthermore, the Calquence combination regimen provided a median progression-free survival (mPFS) of 66.4 months, almost 1.5 years longer than the 49.6 months observed with SoC.
Calquence’s safety profile in trial was found to be in line with previous data without any new safety concerns identified.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “The priority review acceptance reinforces the potential of Calquence to transform outcomes in untreated mantle cell lymphoma. Data from the ECHO trial showed Calquence plus chemoimmunotherapy significantly delayed disease progression and showed a trend to improved survival in patients with this currently incurable blood cancer.
“We are working closely with the FDA to provide patients this potential new treatment as soon as possible.”