The U.S. Food and Drug Administration has approved a new treatment for two rare types of non-Hodgkin lymphoma: Poteligeo® (mogamulizumab-kpkc). Poteligeo® has been approved to treat adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
Mycosis fungoides and Sézary syndrome are two types of cutaneous T-cell lymphoma (CTCL), which are lymphomas that arise in the skin. Mycosis fungoides is the most common sub-type and accounts for approximately 50% of all cases. Sézary syndrome, on the other hand, only accounts for approximately 3% of all cases, but is a more aggressive form.
While this approval provides a new and needed treatment option for patients with Mycosis fungoides, this new approval offers the very first treatment option for patients with Sézary syndrome.
Poteligeo® was granted Breakthrough Therapy Designation by the FDA, and was evaluated with Priority Review, which is reserved for drugs that treat a serious condition and, if approved, would provide a significant improvement in treatment safety or effectiveness.
The approval of Poteligeo®
The approval from the FDA is based on the largest randomized trial in Mycosis fungoides and Sézary syndrome, and the first pivotal trial in CTCL to use progression-free survival as a primary endpoint.
The trial, labelled MAVORIC, compared Poteligeo® with vorinostat (Zolinza®) both in terms of progression-free survival and overall response rate. The results of the trial showed that the progression-free survival for Poteligeo® was 7.6 months and 3.1 months for vorinostat, and as for the overall response rate, the results showed a rate of 28% compared to 5% respectively.
Poteligeo® is a registered trademark of Kyowa Kirin, Inc.