FDA approves Kyowa Kirin's Poteligeo for 2 types of rare cancer
Kyowa Kirin received clearance from the Food and Drug Administration for 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 MF and is the first FDA approval of a drug specifically for SS, the agency said upon announcing the drug's approval.
"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. director of 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. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients."
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. MF and SS are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. MF 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. SS 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 FDA said approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either Poteligeo or a type of chemotherapy called vorinostat. Progression-free survival, or the 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), according to the FDA.
The FDA said it granted this application Priority Review and Breakthrough Therapy designation. Poteligeo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
"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. director of 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. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients."
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. MF and SS are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. MF 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. SS 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 FDA said approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either Poteligeo or a type of chemotherapy called vorinostat. Progression-free survival, or the 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), according to the FDA.
The FDA said it granted this application Priority Review and Breakthrough Therapy designation. Poteligeo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.