FDA Approves Poteligeo (Mogamulizumab) for Lymphoma of the Skin

The US Food and Drug Administration (FDA) has approved Poteligeo (mogamulizumab) to treat people with some types of skin lymphoma. Skin lymphoma is a cancer of the white blood cells that starts in the skin. Poteligeo is for adults with mycosis fungoides (MF) or Sezary syndrome (SS) who had previous systemic (whole-body) treatment, and whose cancer didn’t get better, or got better but came back.

The drug approval provides a new treatment option for MF and is the first FDA approval of a drug specifically for SS. The FDA evaluated Poteligeo through its fast track, breakthrough therapy, and priority review programs, which are meant to speed up the availability of drugs to treat serious diseases. Poteligeo also received orphan product designation, which provides incentives to developers for drugs intended to treat a rare disease.

The FDA based its approval on a clinical trial of 372 people with MF or SS that had come back after treatment. Participants received either Poteligeo or Zolinza (vorinostat), a type of targeted therapy. The trial was designed to measure progression-free survival, which is how long a patient lives without the cancer growing. For patients taking Poteligeo, progression-free survival was an average 7.6 months compared to 3.1 months for patients taking Zolinza.

Poteligeo is given intravenously (as an IV). It’s a monoclonal antibody that attaches to a protein called CC chemokine receptor type 4 (CCR4) and stops it from helping cancer cells grow.

The most common side effects include rash, infusion-related reactions, fatigue, diarrhea, muscle and joint pain, and upper respiratory tract infection. Serious warnings include the risk for dangerous skin reactions, infusion reactions, infections, autoimmune problems, and complications of allogeneic stem cell transplant after taking the drug.

Poteligeo is marketed by Kyowa Kirin, Inc.