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The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for mogamulizumab.
Mogamulizumab is a humanized monoclonal antibody directed against CCR4 that is being developed by Kyowa Hakko Kirin Co., Ltd.
The company is seeking FDA approval for mogamulizumab as a treatment for patients with cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy.
The FDA expects to make a decision on the BLA by June 4, 2018.
The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
The BLA for mogamulizumab is supported by data from the MAVORIC study, the largest global randomized clinical trial of systemic therapy in CTCL.
MAVORIC is a phase 3 trial in which researchers evaluated mogamulizumab and an active comparator in 372 patients with CTCL who had failed at least 1 prior systemic treatment. The study was conducted in the US, Europe, Japan, and Australia.
Results from this trial are scheduled to be presented at the 2017 ASH Annual Meeting (abstract 817).
The FDA previously granted mogamulizumab breakthrough therapy designation as a treatment for CTCL patients who have received at least 1 prior systemic therapy.
Breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions. The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.
To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
