Posted from: Monday, September 17, 2018 - 12:07 PM - Present

Poteligeo Approved to Treat Rare Forms of Lymphoma

August 8, 2018 – The U.S. FDA has approved Poteligeo® (mogamulizumab-kpkc), manufactured by Kyowa Kirin Inc., to treat two rare types of non-Hodgkin lymphoma. Eligible patients are adults who have been diagnosed with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS), and who have already received at least one prior systemic therapy. Poteligeo is the first drug to receive FDA approval to treat Sézary syndrome.

In both types of cancer, malignant lymphocytes (a type of white blood cell) migrate to the skin, where they cause rashes and skin lesions. From there, the cancer can spread to other parts of the body. SS lymphoma typically spreads more quickly and widely than MF lymphoma, and can be more challenging to treat. In some cases, patients who are initially diagnosed with MF lymphoma may develop SS lymphoma. The prognosis for patients with either form of non-Hodgkin lymphoma varies based on the stage of the disease, the patient’s age, and other factors.

Patients receive Poteligeo via intravenous (IV) infusion in 28-day cycles. During the first cycle, infusions are given once a week for four weeks. In subsequent cycles, Poteligeo is administered once every two weeks. The recommended dose is based on the patient’s weight, and treatment should continue until cancer progression or treatment intolerance. In a clinical trial, Poteligeo delivered progression-free survival (PFS) that lasted an average of 7.6 months versus 3.1 months on chemotherapy with vorinostat.

Poteligeo has been launched at an average wholesale price of $4,548 per vial.

Last Updated Friday, October 19, 2018 - 01:30 AM.