FDA Approves Monoclonal Antibody for Rare Types of NHL Affecting the Skin
Posted: Friday, August 10, 2018
The U.S. Food and Drug Administration (FDA) recently approved the monoclonal antibody mogamulizumab-kpkc (Poteligeo) for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Mycosis fungoides and Sézary syndrome are rare types of non-Hodgkin lymphoma (NHL) that affect the skin.
This approval was based on the results of a clinical trial involving 372 patients with relapsed mycosis fungoides or Sézary syndrome who received either mogamulizumab-kpkc or vorinostat. Progression-free survival for the mogamulizumab-kpkc arm was 7.6 months compared with 3.1 months for the vorinostat arm. The most common side effects associated with mogamulizumab-kpkc included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious warnings of treatment with this agent include the risk of dermatologic toxicity, infusion reactions, autoimmune problems, and complications of allogeneic stem cell transplantation.