Neratinib - Puma Biotechnology
Alternative Names: CAN 030; HKI-272; NERLYNX; Nerlynx; NERLYNX SKU; Ouyoubi; PB-272Latest Information Update: 12 Jul 2024
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 Amides; Aniline compounds; Antineoplastics; Carboxylic acids; Chlorobenzenes; Dimethylamines; Ethers; 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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 31 May 2024 Efficacy and adverse event data from the phase II SUMMIT trial in Solid tumors presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)
- 05 Apr 2024 Efficacy data from the phase II I-SPY trial in Breast cancer presented at the 115th Annual Meeting of the American Association for Cancer Research (AACR-2024)
- 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)