Neratinib - Puma Biotechnology
Alternative Names: CAN 030; HKI-272; NERLYNX; Nerlynx; NERLYNX SKU; PB-272Latest Information Update: 14 Feb 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 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
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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
- 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)