Neratinib

Drug Profile

Neratinib

Alternative Names: HKI-272; PB-272

Latest Information Update: 03 Mar 2017

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 02 Mar 2017 M.D. Anderson Cancer Center, Pfizer and Puma Biotechnology plan a phase I trial for Solid tumours (Metastatic-disease, Late-stage disease, Second-line therapy or greater, Combination therapy) in USA (NCT03065387)
  • 01 Mar 2017 Puma Biotechnology plans to modify summary of product characteristics for MAA submitted with EMA for Breast cancer (Adjuvant therapy, Early-stage disease, Second-line therapy or greater)
  • 12 Dec 2016 Phase-II clinical trials in Breast cancer (Metastatic disease, Combination therapy, Second-line therapy or greater, Locally recurrent) in United Kingdom (PO) (ISRCTN16945804)
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