Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome
- Poteligeo has been approved for the treatment of the two most common types of Cutaneous T-cell lymphoma (CTCL) in previously treated patients based on data showing improved progression-free survival (PFS) and overall response rate (ORR) when compared to vorinostat.
- FDA approval was based on MAVORIC, the largest randomized study conducted in patients with mycosis fungoides (MF) and Sézary syndrome (SS), subtypes of CTCL, and the first pivotal trial in CTCL to use PFS as a primary endpoint.
- Poteligeo is the first biologic agent targeting CCR4 to be available for patients in the U.S.
Tokyo, Japan, 8th August, 2018 – Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo® (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. FDA granted Priority Review and Breakthrough Therapy Designation in late 2017.
Poteligeo is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain blood cancers including CTCL. Using the proprietary POTELLIGENT® technology, the amount of fucose in the sugar chain structure of Poteligeo is reduced, which enhances the antibody dependent cellular cytotoxicity (ADCC).
“I believe the approval is very good news for patients who have been suffering from mycosis fungoides (MF) or Sézary syndrome (SS) in the US,” said Mitsuo Satoh Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. “Since this antibody was discovered through our cutting-edge R&D activity, it is also another important achievement for Kyowa Hakko Kirin in leaping forward to become a global specialty pharmaceutical company.”