LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Thursday said its supplemental New Drug Application (sNDA) for Calquence has been granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with previously untreated mantle cell lymphoma (MCL), a rare and typically aggressive form of non-Hodgkin lymphoma (NHL).
The Prescription Drug User Fee Act (PDUFA) date or a decision from the regulator is expected during the first quarter of 2025.
The priority review is based on results from ECHO Phase 3 study which showed Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27 percent compared to standard-of-care chemoimmunotherapy.
The submission is being reviewed under Project Orbis, an initiative of the FDA which provides a framework for concurrent submission and review of oncology medicines among participating international partners to bring cancer treatments to patients around the world as early as possible.
Calquence is indicated to treat adults with mantle cell lymphoma who have received at least one prior therapy. It is also approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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