WASHINGTON, Aug. 8 (Xinhua) -- The United States Food and Drug Administration (FDA) approved on Wednesday a new drug for two rare, hard-to-treat types of non-Hodgkin lymphoma.
FDA approved Poteligeo injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy.
The approval provided a new option for patients with MF and was the first FDA approval of a drug specifically for SS.
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 and 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 CCR4 found on some cancer cells.
The 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.
The trial showed that the amount of time a patient stayed alive without the cancer growing was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat (median 3.1 months).