Neratinib - Puma Biotechnology

Drug Profile

Neratinib - Puma Biotechnology

Alternative Names: CAN 030; HKI-272; Nerlynx; PB-272

Latest Information Update: 14 Aug 2018

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At a glance

  • Originator Wyeth
  • Developer City of Hope National Medical Center; M. D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; NSABP Foundation; 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; Protein tyrosine kinase inhibitors
  • 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 Colorectal cancer; Non-small cell lung cancer; Solid tumours
  • Phase I/II Haematological malignancies

Most Recent Events

  • 31 Jul 2018 Preregistration for Breast cancer (Early-stage disease, Adjuvant therapy) in Canada (PO)
  • 17 Jul 2018 Puma Biotechnology and Strata Oncology entered into a clinical trial agreement to accelerate patient enrolment in phase II SUMMIT trial of neratinib for Solid tumours
  • 29 Jun 2018 Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for MAA for neratinib for Breast cancer (Early-stage disease, Adjuvant therapy)
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