Neratinib is under clinical development by Puma Biotechnology and currently in Phase I for Ovarian Cancer. According to GlobalData, Phase I drugs for Ovarian Cancer have a 73% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. 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. It focuses on developing and commercializing novel therapeutics for the treatment of cancer. The company’s product portfolio consists of Nerlynx (neratinib) tablets, a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and cancer that has spread to other parts of the body (metastatic). Its product pipeline also consists of Alisertib, a selective, small-molecule inhibitor of aurora kinase A that is used in the treatment of non small cell lung cancer and breast cancer. The company manufactures, supplies, stores and distributes its products through 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.
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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.
