The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least 1 prior systemic therapy—2 rare types forms of non-Hodgkin lymphoma. Not only is this treatment the first FDA approval of a drug specifically for Sézary syndrome, but it also provides a new treatment option for patients with mycosis fungoides.
“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a recent statement
. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”
Findings yielded from a clinical trial consisting of 372 patients with relapsed mycosis fungoides or Sézary syndrome who received either mogamulizumab-kpkc or a type of chemotherapy called vorinostat served as the basis for the approval. Investigators found that patients who took mogamulizumab-kpkc had a longer progression-free survival (median 7.6 months) compared with patients taking vorinostat (median 3.1 months).
Rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection were listed as the most common adverse effects associated with mogamulizumab-kpkc treatment. Serious warnings for the use of treatment with mogamulizumab-kpkc includes the following: risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with the drug.
Mycosis fungoides and Sézary syndrome are types of non-Hodgkin lymphoma, a rare blood cancer that starts in white blood cells called lymphocytes and can affect the skin. About half of all lymphomas arising from the skin can be accounted for by mycosis fungoides, which causes itchy red rashes and skin lesions that can spread to other parts of the body. Sézary syndrome is a rare form of skin lymphoma that affects the blood and lymph nodes.
Mogamulizumab-kpkc is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.
Previously, mogamulizumab-kpkc was granted a priority review, a breakthrough therapy designation, and an orphan drug designation by the FDA.