Medication Monitor

Generic Name (Trade Name—Company)
August 16, 2018


(Poteligeo—Kyowa Kirin)
FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approved mogamulizumab-kpkc injection for I.V. 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 agent is a monoclonal antibody that binds to a CC chemokine receptor type 4 (CCR4) found on some cancer cells. 

Approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either mogamulizumab-kpkc or a type of chemotherapy called vorinostat. Progression-free survival was longer for patients taking mogamulizumab-kpkc (median 7.6 mo) compared with patients taking vorinostat (median 3.1 mo).

In clinical trials, the most common adverse effects of treatment included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.

Serious warnings include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with the drug.