Neratinib is under clinical development by Puma Biotechnology and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Neratinib’s likelihood of approval (LoA) and phase transition for Prostate Cancer took place on 19 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Neratinib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Neratinib overview

Neratinib ( Nerlynx) is a member of the 4-anilino quinolidine acts as antineoplastic agent. It is formulated as film-coated tablets for oral route of administration. Neratinib is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy, and in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Neratinib is under development for the treatment of advanced cancers such as metastatic castration-resistant prostate cancer, HER2-negative metastatic breast cancer and triple negative breast cancer, hormone receptor (HR)-positive/HER2-negative metastatic breast cancer, gallbladder cancer, metastatic biliary tract cancer, HER2 positive metastatic breast cancer, triple-negative breast cancer, HER2 non-small cell lung cancer, salivary gland, bladder/urinary tract cancer, metastatic colorectal cancer, endometrial cancer, gastric/esophageal cancer, ovarian cancer, cervical cancer, metastatic biliary duct (bile duct) cancer, glioblastoma multiforme, adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, breast cancer patients with brain metastases (metastatic brain tumor) and solid tumors. It is administered through oral and intravenous routes. It was also under development for the treatment of chronic liver disease.

Puma Biotechnology overview

Puma Biotechnology (Puma) is a biopharmaceutical company that develops novel therapeutics for the treatment of cancer. The company develops and commercializes drug candidates, namely, PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Its pipeline portfolio also encompasses investigational candidates for various indications such as adjuvant breast cancer, gastric cancer, metastatic breast cancer and HER2-positive breast cancer and other cancers. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. Puma manufacture and distribute its products through the third party contractors. Puma is headquartered in Los Angeles, California, the US.

Quick View Neratinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Neratinib
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.