Likelihood of Approval and Phase Transition Success Rate Model – Abemaciclib in Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET)

Empower your strategies with our Likelihood of Approval and Phase Transition Success Rate Model – Abemaciclib in Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET) report and make more profitable business decisions.

This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.

Abemaciclib in Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET) Drug Details:

Abemaciclib (Verzenio / Verzenios / Yulareb / Zenlistik) is a benzimidazole derivative, acts as an anti-tumor or anti-neoplastic agent. It is formulated as tablets and film coated tablets for the oral route of administration. Verzenio is indicated in combination with fulvestrant for the treatment of women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy. It is also indicated as monotherapy for the treatment of adult patients with hormone receptor positive and HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting and also indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer. Verzenio is indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, nodepositive, early breast cancer at high risk of recurrence and a Ki-67 score =20% as determined by an FDA approved test.Abemaciclib is under development for the treatment of Kaposi sarcoma, metastatic gastroesophageal junction adenocarcinoma, neuroblastoma, platinum-resistant ovarian cancer, adenocarcinoma of the prostate, neurofibromatosis 1,esophageal cancer, cholangiocarcinoma, retinoblastoma, leiomyosarcoma and dedifferentiated liposarcoma, urothelial cancer, metastatic castration-resistant prostate cancer, advanced and metastatic solid tumors such as colorectal cancer, relapsed/ refractory multiple myeloma, metastatic melanoma, glioblastoma multiforme, astrocytoma, meningioma, ependymoma, oligodendroglioma, lymphoma, primary CNS lymphoma, IDH mutant glioma, recurrent head, and neck squamous cell carcinoma, Hormone receptor positive and HER2 negative breast cancer, metastatic breast cancer, endometrial cancer, malignant mesothelioma,  relapsed or refractory mantle cell lymphoma, non-small cell lung cancer including squamous non-small cell lung cancer, neuroendocrine gastroenteropancreatic tumors (GEP-NET), metastatic renal cell carcinoma, pediatric diffuse intrinsic pontine glioma, dedifferentiated liposarcoma, Ewing’s sarcoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, adipocytic sarcoma and gastroesophageal junction adenocarcinoma, high-grade glioma, anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma. The drug candidate is a new chemical entity (NCE).The drug candidate was under development for the treatment of pancreatic ductal adenocarcinoma, hepatocellular carcinoma, gastric cancer and human epidermal growth factor receptor 2 (HER2) positive, early breast cancer, metastatic biliary tract carcinoma, gallbladder cancer, ampullary cancer, intra, extra-heaptic bile duct cancer and high-risk metastatic hormone-sensitive prostate cancer.

Report Coverage

The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.

The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.

Quick View – Abemaciclib LOA Data
Report Segments	· Drug type · Intervention type
Drug Name	· Abemaciclib
Administration Pathway	· Oral
Therapeutic Areas	· Genetic Disorders| Oncology
Key Manufacturers	· Eli Lilly and Co
Drug Development Status	· Marketed

Reasons to Buy

• Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
• Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
• Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
• Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.

Scope

• Drug Details: Drug name, Drug type, Intervention type
• Administration Pathway
• Therapeutic Areas
• Key Manufacturers
• Drug Development Status

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