The FDA ( U.S. Food and Drug Administration ) has approved Poteligeo ( Mogamulizumab-kpkc ) injection for intravenous use 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 mycosis fungoides and is the first FDA approval of a drug specifically for Sézary syndrome.
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.
Mycosis fungoides and Sézary syndrome are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin.
Mycosis fungoides accounts for about half of all lymphomas arising from the skin. It causes itchy red rashes and skin lesions and can spread to other parts of the body.
Sézary syndrome is a rare form of skin lymphoma that affects the blood and lymph nodes.
Poteligeo is a monoclonal antibody that binds to a protein ( called CC chemokine receptor type 4 or CCR4 ) found on some cancer cells.
The approval was based on a clinical trial of 372 patients with relapsed mycosis fungoides or Sézary syndrome who received either Poteligeo or a type of chemotherapy called Vorinostat.
Progression-free survival (t he amount of time a patient stays alive without the cancer growing ) was longer for patients taking Poteligeo ( median 7.6 months ) compared to patients taking Vorinostat ( median 3.1 months ).
The most common side effects of treatment with Poteligeo included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection.
Serious warnings of treatment with Poteligeo include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems ( a condition where the immune cells in the body attack other cells or organs in the body ), and complications of stem cell transplantation that uses donor stem cells ( allogeneic ) after treatment with the drug. ( Xagena )
Source: FDA, 2018