The Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMA) scientific committee, has adopted a Positive Opinion recommending approval of the marketing authorisation of mogamulizumab for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin’s lymphoma.

The CHMP’s opinion is now being referred to the European Commission (EC), for a final decision on the grant of a marketing authorisation.

This decision is expected by the end of 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein.

Mogamulizumab is a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukaemic cells of certain haematologic malignancies including CTCL (cutaneous T-cell lymphoma). 

"Mycosis fungoides (MF) and Sézary syndrome (SS) can be disfiguring, debilitating, and even life-threatening, and there are limited treatment options for these rare lymphoma subtypes in Europe today," said Jeffrey S. Humphrey, MD, President of Kyowa Kirin Pharmaceutical Development, Inc. "MAVORIC, the pivotal Phase 3 trial of mogamulizumab, is the largest study of systemic therapy ever conducted in MF and SS. The study showed that mogamulizumab prolonged progression-free survival compared to vorinostat in patients with MF or SS. We will continue to work with the scientific community to advance the understanding of these complex diseases, and we look forward to working with health authorities to bring this important new option to Europe."

The EMA’s scientific committee, CHMP adopted a Positive Opinion recommending the approval of the marketing authorisation of mogamulizumab for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

The CHMP’s recommendation is now being referred to the European Commission (EC), which is expected to render its final decision by the end of 2018.

Source: Kyora Hakko Kirin