Rare Daily Staff
The U.S. Food and Drug Administration today approved Kyowa Kirin’s Poteligeo for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome, rare, hard-to-treat types of non-Hodgkin lymphoma
The approved use of Poteligeo is after at least one prior systemic therapy. It is the first FDA approval of a therapy specifically for Sézary syndrome.
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. In the case of mycosis fungoides or Sézary syndrome, lymphocytes become cancerous and affect the skin.
Poteligeo is a monoclonal antibody that binds to CC chemokine receptor type 4 or CCR4, a protein found on some cancer cells.
The approval was based on a clinical trial of 372 patients with relapsed mycosis fungoides or Sézary syndrome who received either Poteligeo or a type of chemotherapy called vorinostat. Progression-free survival was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat (median 3.1 months).
The most common side effects of treatment with Poteligeo included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection.
Serious warnings of treatment with Poteligeo include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation that uses donor stem cells after treatment with the drug.
The FDA 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.
August 8, 2018