Neratinib - Puma Biotechnology

Drug Profile

Neratinib - Puma Biotechnology

Alternative Names: HKI-272; Nerlynx; PB-272

Latest Information Update: 11 Oct 2017

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At a glance

  • Originator Wyeth
  • Developer City of Hope National Medical Center; Memorial Sloan-Kettering Cancer Center; Pfizer; Puma Biotechnology; University of California at San Francisco
  • Class Antineoplastics; Nitriles; Pyridines; Quinolines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists; ERBB 2 receptor antagonists; ERBB 4 receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer
  • Phase II Non-small cell lung cancer; Solid tumours
  • Phase I/II Haematological malignancies

Most Recent Events

  • 08 Sep 2017 Updated efficacy and adverse events data from the phase III ExteNET trial in Breast cancer presented at the 42nd European Society for Medical Oncology Congress (ESMO-2017)
  • 08 Sep 2017 Five year efficacy and adverse events data from the phase III trial in Breast cancer released by Puma Biotechnology
  • 02 Aug 2017 The Committee for Medicinal Products for Human Use issues Day-180 List of Outstanding Issues for MAA of neratinib for Breast cancer (Early-stage disease, Adjuvant therapy)
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