Ipilimumab by Bristol-Myers Squibb for Metastatic Transitional (Urothelial) Tract Cancer: Likelihood of Approval
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.
Ipilimumab overview
Ipilimumab (Yervoy, Winglore) is a recombinant, human monoclonal antibody belongs to antineoplastic agent. It is formulated as solution, powder for solution and concentrate solution for intravenous route of administration. It is indicated for the treatment of unresectable or metastatic melanoma. Yervoy also used as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Yervoy in combination with opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in previously untreated adults. It is also indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years of age and older, and nivolumab (Opdivo) in combination with ipilimumab (Yervoy), as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and also nivolumab in combination with ipilimumab ( and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Yervoy in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult patients. Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer.
The drug candidate is under development for the treatment of chronic lymphocytic leukemia (CLL), homologous-recombination deficient (HRD) metastatic adenocarcinoma of the pancreas, Richter transformation (RT), relapsed/refractory multiple myeloma, hepatocellular carcinoma, gastric cancer, metastatic neuroendocrine prostate cancer (NEPC), metastatic advanced uveal melanoma, neurofibromatosis type 1 (NF1), malignant peripheral nerve sheath tumors (MPNST), metastatic urothelial carcinoma, metastatic renal cell carcinoma, cutaneous melanoma, glioblastoma multiforme (GBM), gliosarcoma, Merkel cell carcinoma, solid tumors including liver cancer, lung cancer and adrenal gland cancer, chronic myelocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, Hodgkin lymphoma, acute myelocytic leukemia, acute lymphocytic leukemia, myelodysplastic syndrome and chronic lymphocytic leukemia. Yervoy in combination with Opdivo is indicated for the first-line treatment of unresectable, advanced or recurrent esophageal cancer in adults. Yervoy in combination with Opdivo as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
It was also under development for transitional cell cancer (urothelial cell cancer, breast cancer, adenocarcinoma, squamous non-small cell lung cancer, metastatic prostate cancer (as a first line therapy), metastatic hormone refractory (castration-resistant, androgen-independent) prostate cancer, ovarian cancer and melanoma. It was under development for the treatment of human immunodeficiency virus (HIV) infection and diffuse large B cell lymphoma.
Bristol-Myers Squibb overview
Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, medical professionals, hospitals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.
For a complete picture of Ipilimumab’s drug-specific PTSR and LoA scores, buy the report here.
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.
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