ARTICLE | Clinical News

Kyowa's Poteligeo meets in Phase III for CTCL

December 10, 2017 8:06 PM UTC

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said Poteligeo mogamulizumab (AMG 761, KW-0761) met the primary endpoint of improving progression-free survival (PFS) in the Phase III MAVORIC trial to treat mycosis fungoides or Sézary syndrome, which are both subtypes of cutaneous T cell lymphoma.

In November, FDA accepted and granted Priority Review to a BLA for Poteligeo to treat CTCL in patients who have received at least one prior systemic therapy. The PDUFA date is June 4, 2018. The BLA is supported by the MAVORIC data (see BioCentury Extra, Nov. 28)...