The FDA grants mogamulizumab Breakthrough Therapy Designation for relapsed/refractory Cutaneous T-Cell Lymphoma

On 25th August 2017, mogamulizumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Mycosis Fungoides (MF) or Sézary Syndrome (SS) and who have received one or more prior systemic therapies.

Mogamulizumab is a humanized monoclonal antibody, which targets and blocks C-C Chemokine Receptor 4 (CCR4) thereby initiating antibody dependent cellular cytotoxicity against CCR4-positive T-cells as well as inhibiting chemokine-mediated cellular migration, T-cell proliferation, and chemokine-mediated angiogenesis.

The BTD was granted based on results from the mogamulizumab anti-CCR4 antibody versus comparator in CTCL (MAVORIC) trial; a phase III, open-label, multicenter, randomized trial of mogamulizumab versus vorinostat in patients with relapsed/refractory MF or SS (NCT01728805). The study is taking place in the US, Australia, Japan, and Europe. Overall, 372 patients have been included in the study and estimated study completion is December 2018.

  1. Markets Insider. US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the Treatment of Mycosis Fungoides and Sézary Syndrome. 2017 Aug 25. http://markets.businessinsider.com/news/stocks/US-Food-and-Drug-Administration-Grants-Breakthrough-Therapy-Designation-for-Mogamulizumab-for-the-Treatment-of-Mycosis-Fungoides-and-S%C3%A9zary-Syndrome-1002284390. [Accessed 2017 Aug 25].
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