New York, NY (August 8, 2018) –The U.S. Food and Drug Administration (FDA) announced it has approved the use of Mogamulizumab-kpkc (Poteligeo) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.
This approval is based on a clinical trial of 372 patients with relapsed MF or SS who received either mogamulizumab or a type of chemotherapy called vorinostat. Progression-free survival was longer for patients taking mogamulizumab compared to patients taking vorinostat.
“Today’s approval shows significant progress in the understanding of this disease,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “Mycosis fungoides (MF) and Sézary syndrome (SS) are the two most common types of the disease and this approval offers treatment options for a subtype that previously had limited options and a new opportunity for hope for those impacted by these diseases.”