Mogamulizumab - Kyowa Hakko Kirin

Drug Profile

Mogamulizumab - Kyowa Hakko Kirin

Alternative Names: AMG 761; KW-0761; Poteligeo

Latest Information Update: 04 Dec 2017

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At a glance

  • Originator Kyowa Hakko
  • Developer Amgen; Bristol-Myers Squibb; Kyowa Hakko Kirin
  • Class Antiasthmatics; Antineoplastics; Monoclonal antibodies
  • Mechanism of Action CCR4 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Cutaneous T cell lymphoma; Peripheral T-cell lymphoma; Adult T-cell leukaemia-lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Adult T-cell leukaemia-lymphoma; Cutaneous T cell lymphoma; Peripheral T-cell lymphoma
  • Phase III Spinal cord disorders
  • Phase I/II Solid tumours
  • Phase I Non-small cell lung cancer
  • Research Mycosis fungoides; Sezary syndrome
  • Discontinued Asthma; Hypersensitivity

Most Recent Events

  • 30 Nov 2017 Kyowa Hakko Kirin files supplemental application to remove pre-treatment diagnostic requirement and to change dosing schedule of mogamulizumab for cutaneous T-cell lymphoma (Second-line therapy or greater) in Japan
  • 28 Nov 2017 Preregistration for Cutaneous T-cell lymphoma (Monotherapy, Second-line therapy or greater) in USA (IV)
  • 28 Nov 2017 FDA assigns PDUFA action date of 04/06/2018 for Mogamulizumab for Cutaneous T-cell lymphoma (Monotherapy, Second-line therapy or greater) in USA (IV)
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