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FDA Grants Mogamulizumab Priority Review for CTCL

Jason M. Broderick @jasoncology
Published: Tuesday, Nov 28, 2017

mcl
The FDA has granted a priority review to a biologics license application (BLA) for mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy, according to Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody.

TEAEs more common with vorinostat versus mogamulizumab included diarrhea (61.8% vs 23.4%), nausea (42.5% vs 15.2%), thrombocytopenia (30.6% vs 11.4%), dysgeusia (29.0% vs 3.3%), and increased blood creatinine (28.0% vs 3.3%).
Kim YH, MD, Bagot M, Pinter-Brown L et al. Anti-CCR4 monoclonal antibody, mogamulizumab, demonstrates significant improvement in PFS compared to vorinostat in patients with previously treated cutaneous T-Cell lymphoma (CTCL): results from the phase III MAVORIC study. Abstract available ahead of 2017 ASH Annual Meeting; December 9-12, 2017; Atlanta, GA. Abstract 817.

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