11:31 AM
Aug 08, 2018
 |  BC Extra  |  Company News

FDA approves Kyowa's Poteligeo for CTCL

FDA approved Poteligeo mogamulizumab-kpkc from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat the two most common forms of cutaneous T cell lymphoma.

The agency approved Poteligeo to treat adults with relapsed or refractory mycosis fungoides or Sézary syndrome who have already received one prior systemic therapy.

Poteligeo, a humanized mAb against CC chemokine receptor 4 (CCR4; CD194), has breakthrough therapy status for the indications. After extending the review by three months to review manufacturing information, the agency approved Poteligeo well ahead of its Sept. 4 PDUFA date. The application had Priority Review.

Kyowa's BLA submission for Poteligeo included data from the Phase III MAVORIC trial in which the drug led to a significant progression-free survival (PFS) benefit over histone deacetylase (HDAC) inhibitor Zolinza vorinostat from Merck & Co. Inc. (NYSE:MRK). Zolinza is approved for CTCL. Kyowa said MAVORIC was the first pivotal trial of a CTCL therapy to use PFS rather than response rate as the primary endpoint.

Kyowa, which plans to launch Poteligeo in the U.S. next quarter, declined to disclose the drug's price. The drug is under EMA review, and is approved in Japan.

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