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Neratinib - Puma Biotechnology

Drug Profile

Neratinib - Puma Biotechnology

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

Latest Information Update: 19 Mar 2024

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At a glance

  • Originator Wyeth
  • Developer CANbridge Pharmaceuticals; City of Hope National Medical Center; Fox Chase Cancer Center; M. D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; National Comprehensive Cancer Network; Novartis Oncology; NSABP Foundation; Pfizer; Pint Pharma; Puma Biotechnology; Specialised Therapeutics Asia; 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; Glioblastoma; Non-small cell lung cancer; Prostate cancer; Solid tumours
  • Phase I/II Haematological malignancies
  • Phase I Gastric cancer

Most Recent Events

  • 12 Mar 2024 Puma Biotechnology terminates phase II SUMMIT trial in Solid tumors (Monotherapy) in the US, Australia, Canada, Serbia, Belgium, Denmark, Finland, France, Italy, Israel, Ireland, South Korea, Spain, and the UK (PO) (NCT01953926)
  • 05 Dec 2023 Efficacy and adverse event data from the phase II trial in Breast cancer presented at the 46th Annual San Antonio Breast Cancer Symposium (SABCS-2023)
  • 03 Aug 2023 Launched for Breast cancer (Early-stage disease, Adjuvant therapy) in China (PO) prior to August 2023
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