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Neratinib - Puma Biotechnology

Drug Profile

Neratinib - Puma Biotechnology

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

Latest Information Update: 02 Oct 2021

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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; Prostate cancer; Solid tumours
  • Phase I/II Haematological malignancies

Most Recent Events

  • 20 Sep 2021 Biomarkers information updated
  • 05 Aug 2021 Puma Biotechnology announces intention to conduct a meeting with the US FDA to the potential for an accelerated approval pathway for neratinib in Non-small cell lung cancer (Second-line therapy or greater) in 2022
  • 05 Aug 2021 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 in the fourth quarter of 2021
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