Neratinib is under clinical development by Puma Biotechnology and currently in Phase II for Gastric Cancer. According to GlobalData, Phase II drugs for Gastric Cancer have a 28% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Neratinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Neratinib overview

Neratinib (Nerlynx) is a member of the 4-anilino quinolidine acts as antineoplastic agent. It is formulated as film-coated tablets and tablets for oral route of administration. Nerlynx 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  HER2-negative metastatic breast cancer and triple negative breast cancer, hormone receptor (HR)-positive/HER2-negative metastatic breast cancer, HER2 positive metastatic breast cancer, triple-negative breast cancer, HER2 non-small cell lung cancer, metastatic colorectal cancer, endometrial cancer, ovarian cancer,  glioblastoma multiforme, adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, breast cancer patients with brain metastases (metastatic brain tumor), gastroesophageal junction adenocarcinoma and solid tumors. It is administered through oral and intravenous routes. It was also under development for the treatment of chronic liver disease, salivary gland, bladder/urinary tract cancer, metastatic biliary tract cancer and metastatic castration-resistant prostate cancer, gallbladder cancer,  metastatic biliary duct (bile duct) cancer, gastric/esophageal cancer, cervical cancer, 

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. The company’s 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.

For a complete picture of Neratinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.