Poteligeo (mogamulizumab-kpkc) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides and Sézary syndrome — two types of cutaneous T-cell lymphoma — in patients who failed at least one prior line of systemic therapy.
The approval assures a new treatment option for mycosis fungoides (MF) patients and makes Poteligeo the first FDA-approved therapy for Sézary syndrome.
“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin’s lymphoma and this approval fills an unmet medical need for these patients,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release.
“We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatment for patients,” added Pazdur, who also is acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Both MF and Sézary syndrome are lymphomas arising in the skin. MF, the most common type of cutaneous T-cell lymphoma (CTCL), causes itchy red rashes and skin lesions and can spread to other parts of the body. Sézary syndrome is a rare type of skin lymphoma affecting Sézary cells (a kind of T cell), which can be found in the skin, blood, and lymph nodes.
Poteligeo is a monoclonal antibody that recognizes the CCR4 protein, found at high levels in leukemia and certain lymphoma subtypes, such as CTCL. When it binds to CCR4, Poteligeo recruits and activates immune cells to mount an attack on the cancer cells containing the protein.
The medicine has received breakthrough therapy and orphan drug designation by the FDA for treating CTCL. In November 2017 the application requesting Poteligeo’s approval for the condition also was granted priority review.
The designations and recent approval were all based on results from the MAVORIC Phase 3 open label trial (NCT01728805). It tested Poteligeo versus a type of chemotherapy called Zolinza (vorinostat) on 372 patients with MF or Sézary syndrome who had failed at least one prior line of systemic treatment.
Participants receiving Poteligeo survived longer without their cancer growing (7.6 months) than patients taking Zolinza (3.1 months).
Rash, infusion-related reaction, diarrhea, fatigue, muscle pain, and respiratory infections were among the most frequent side effects of Poteligeo treatment.
Despite the promising results achieved in the Phase 3 trial and the FDA’s approval, researchers warn of the risk of Poteligeo to cause skin toxicity, infections, infusion reactions, autoimmune problems — a condition where immune cells react against the patient’s own body — and complications from stem cell transplant after Poteligeo treatment.
