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Neratinib - Puma Biotechnology

Drug Profile

Neratinib - Puma Biotechnology

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

Latest Information Update: 13 Nov 2019

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At a glance

  • Originator Wyeth
  • Developer CANbridge Pharmaceuticals; City of Hope National Medical Center; M. D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; NSABP Foundation; Pfizer; Pint Pharma; 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.

    Yes - Breast cancer
  • 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

  • 06 Nov 2019 Puma Biotechnology announces intention to conduct a pre-NDA meeting with the US FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive Breast cancer and HER2 mutated Cervical cancer in the fourth quarter of 2020 or the first half of 2021
  • 06 Nov 2019 Registered for Breast cancer (Early-stage disease, Adjuvant therapy) in Hong Kong (PO)
  • 23 Oct 2019 NICE recommends availability of neratinib for breast cancer in United Kingdom
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