FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Treatment for Two Rare Lymphomas

Aug. 10, 2018

The FDA approved a new drug for two rare forms of non-Hodgkin lymphoma.

Adult patients with either mycosis fungoides or Sezary syndrome can try Kyowa Kirin’s Poteligeo (mogamulizumab-kpkc) as an IV treatment as long as they’ve tried at least one systemic treatment such as chemotherapy, the agency said.

Poteligeo is a monoclonal antibody that binds to a protein on some cancer cells. It is the first treatment ever approved for Sezary syndrome, which is the most virulent of the two diseases (its median prognosis is about four years).

The approval was based on a clinical trial with 372 patients showing that patients who took the drug lived longer, on average, without seeing their cancers grow compared to a chemotherapy treatment. The median progression-free survival was 7.6 months for Poteligeo patients compared to a median of 3.1 months for patients on chemotherapy, the FDA said.

View today's stories