EMA grants approval to mogamulizumab (Poteligeo®) for patients with previously treated cutaneous T-cell lymphoma

On 26 November 2018, mogamulizumab (Poteligeo®), a humanized monoclonal antibody directed against the CC chemokine receptor 4 (CCR4), received marketing authorization from the European Medicines Agency (EMA) for the treatment of adult patients with previously treated cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) or Sézary syndrome (SS), who have received at least one prior systemic therapy.

The approval granted by the EMA was based on positive results from the international, open-label, randomized, controlled, phase III MAVORIC trial (NCT01728805) comparing mogamulizumab with vorinostat in patients with previously treated MF and SS. Mogamulizumab therapy resulted in superior investigator-assessed progression-free survival in the intent-to-treat population compared with vorinostat therapy (median 7.7 months [95% CI, 5.7–10.3] versus 3.1 months [95% CI, 2.9–4.1] respectively, P < 0.0001).

The phase III trial investigators concluded that mogamulizumab could provide a new, effective treatment for patients with MF and, importantly, for SS, a subtype that represents a major therapeutic challenge in CTCL.

  1. Kyowa Hakko Kirin: Kyowa Kirin announces POTELIGEO® receives marketing authorisation in Europe for the treatment of Mycosis Fungoides and Sézary Syndrome. 2018 Nov 26. https://www.kyowa-kirin.com/news_releases/2018/e20181126_01.html. [Accessed 2018 Dec 7].
  2. Kim Y. H. et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled, phase 3 trial. Lancet. 2018 Aug 9; 19(9): 1192–1204. DOI:https://doi.org/10.1016/S1470-2045(18)30379-6.
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