ARTICLE | Company News

Kyowa's mogamulizumab gets Priority Review for CTCL

November 28, 2017 6:26 PM UTC

FDA accepted and granted Priority Review to a BLA from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) for Poteligeo mogamulizumab (AMG 761, KW-0761) to treat cutaneous T cell lymphoma in patients who have received at least one prior systemic therapy. The PDUFA date is June 4, 2018.

The BLA is supported by data from the international Phase III MAVORIC trial of Poteligeo in 372 patients with mycosis fungoides or Sézary syndrome, which are both subtypes of CTCL...