New Biologic Therapy Approved for Rare Types of Non-Hodgkin LymphomaAugust 10, 2018
On Wednesday, the Food and Drug Administration (FDA) approved Poteligeo (mogamulizumab-kpkc; Kyowa Hakko Kirin Co. LTD), a new biologic therapy for 2 types of T-cell lymphomas that involve the skin.
Poteligeo is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides and Sézary syndrome after at least 1 prior systemic therapy. The FDA previously granted Poteligeo Breakthrough Therapy designation for this indication. Poteligeo is the first FDA-approved therapy specifically indicated for Sézary syndrome.
FDA approval was based on results of the open-label randomized phase III MAVORIC trial, which found a significant progression-free survival advantage with Poteligeo, compared with vorinostat, in patients with mycosis fungoides or Sézary syndrome who failed to respond adequately to at least 1 prior systemic treatment. These results are not yet published.
Poteligeo will be commercially available in the U.S. during the 4th quarter of 2018.
Food and Drug Administration (FDA). FDA approves treatment for two rare types of non-Hodgkin lymphoma [news release]. August 8, 2018. Available at: click here. Accessed August 9, 2018.