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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: 14 Feb 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

  • 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
  • 21 Mar 2023 Puma Biotechnology terminates a phase II trial for Breast cancer (Combination therapy, Second-line therapy, Late-stage disease, Metastatic disease, Monotherapy, Inoperable/ Unresectable) in USA (PO), due to slow accrual (NCT03289039)
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