FDA Approves Mogamulizumab-kpkc for Mycosis Fungoides, Sézary Syndrome

On August 8, the Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo, Kyowa Kirin, Inc.) for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Approval was based on a randomized, open-label, multicenter trial in patients with active MF or SS after at least one prior systemic therapy. The trial randomized 372 patients to either mogamulizumab-kpkc or vorinostat; progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm.

Read the full FDA press release here.

Posted 8/8/2018