AstraZeneca‘s CALQUENCE (acalabrutinib) has received Priority Review designation from the FDA for treating untreated adult patients with mantle cell lymphoma (MCL). This review status is reserved for drugs that offer substantial improvements over existing therapies.
MCL is an aggressive form of non-Hodgkin lymphoma that affects over 27,500 people worldwide. It is often diagnosed in advanced stages and is typically incurable.
Results from the ECHO Phase III trial showed that CALQUENCE combined with standard-of-care chemoimmunotherapy significantly reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy alone. The addition of CALQUENCE also extended the median progression-free survival (mPFS) by almost 1.5 years, from 49.6 months to 66.4 months.
Overall survival (OS) showed a promising trend in favor of the CALQUENCE combination, although the data is still maturing. The trial will continue to monitor OS as a key secondary endpoint.
The FDA’s review of CALQUENCE is under Project Orbis, a program that facilitates the concurrent submission and review of oncology drugs among participating international partners. The Prescription Drug User Fee Act date for the FDA’s decision is anticipated in the first quarter of 2025.
AstraZeneca is committed to working closely with the FDA to make CALQUENCE available to patients with MCL as soon as possible. This potential new treatment offers significant promise for improving outcomes in this devastating disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
