The European Commission approved the use of Poteligeo (mogamulizumab) for patients with mycosis fungoides or Sézary syndrome — the most common cutaneous T-cell lymphomas — who failed at least one prior systemic therapy.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) — an arm of the European Medicines Agency — and includes all 28 member countries of the European Union, plus Norway, Iceland, and Liechtenstein.
“Mycosis fungoides and Sézary syndrome are horrible conditions which patients literally wear on their skin,” Tom Stratford, CEO of Kyowa Kirin International, said in a press release. “The granting of this marketing authorisation is encouraging news for those across Europe who live with these conditions every day and we look forward to making Poteligeo available for patients and clinicians across Europe.”
Kyowa Kirin International is responsible for commercializing the therapy in Europe.
Poteligeo, administered by infusion, is an inhibitor of CCR4, a molecule used by lymphoma and leukemia cells to travel from the bloodstream into the skin. By blocking this movement, the therapy prevents the development of skin lesions.
“Poteligeo offers a new approach to tackling the underlying disease pathophysiology of mycosis fungoides and Sézary syndrome. By targeting CCR4-expressing T cells in blood and skin we could have a new option to manage patient symptoms,” said professor Martine Bagot, MD, PhD, head of the dermatology department at Hospital Saint Louis in Paris.
Poteligeo’s approvals were based on results from the Phase 3 MAVORIC trial (NCT01728805), where the treatment more than doubled the time until disease progression or death over chemotherapy Zolinza (vorinostat).
The open-label trial included 370 patients with mycosis fungoides or Sézary syndrome who had received at least one prior systemic treatment. Participants were enrolled in 61 centers across the U.S., Europe, Australia, and Japan, and were randomly assigned Poteligeo or Zolinza.
Poteligeo was given as a weekly injection for the first four weeks, and once every two weeks thereafter, while Zolinza was taken orally every day.
Poteligeo treatment reduced the risk for disease progression or death by 53%, with patients living 7.7 months without their cancer worsening, compared with 3.1 months for those on Zolinza.
Responses were also better with Poteligeo, with 35% of patients achieving a best overall global response, versus 6% on the Zolinza arm. Additionally, 44% of patients receiving Poteligeo experienced a 50% or better improvement in their skin lesions, compared with 22% of those on Zolinza.
Patient-reported outcomes measuring skin symptoms, functional status, and well-being also significantly favored Poteligeo.
The rate of severe or life-threatening adverse events was similar among the two treatment groups, and Poteligeo showed no new safety concerns. Infusion-related reactions (34%) and skin eruptions (24%) were the most common adverse effects. Six deaths — three on Poteligeo and three on Zolinza — were considered related to treatment.
“With this approval, now there is a new option for the patients with mycosis fungoides or Sézary syndrome across Europe,” said Mitsuo Satoh, PhD, executive officer and vice president head of the research and development division at Kyowa Kirin.
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