Likelihood of Approval and Phase Transition Success Rate Model – Nivolumab in Angiosarcoma
Powered by
Unlock hidden opportunities in the LoA industry
Empower your strategies with our Likelihood of Approval and Phase Transition Success Rate Model – Nivolumab in Angiosarcoma 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.
Nivolumab in Angiosarcoma Drug Details:
Nivolumab (Opdivo, Opdyta) is a human IgG4 anti-PD-1 monoclonal antibody. Opdivo is formulated as solution and concentrate solution for intravenous and subcutaneous route of administration. Nivolumab is indicated for the treatment of unresectable melanoma, . Opdivo as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo is indicated for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo in combination with ipilimumab, is indicated for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Nivolumab as an adjuvant is indicated for the treatment of urothelial carcinoma. Opdivo is also indicated to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. Opdivo is also indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Opdivo is indicated as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma. Opdivo as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma. Opdivo in combination with ipilimumab is indicated for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. Opdivo indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It is indicated for treatment of recurrent or metastatic squamous cell carcinoma of head and neck. It is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan and for the treatment of adult patients with advanced or metastatic hepatocellular carcinoma (hcc) who are intolerant to or have progressed on sorafenib therapy, and metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, and in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 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, for the treatment of head and neck squamous cell carcinoma, and as the treatment of patients treated with more than two systemic treatment options for advanced or recurrent adenocarcinoma of the stomach or gastroesophageal junction, and is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) metastatic colorectal cancer after prior fuoropyrimidine-based therapy in combination with oxaplatin or irinotecan. Opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). Opdivo in combination with Cabometyx is indicated for the treatment of unresectable or metastatic renal cell carcinoma (RCC) in adults, also indicated for the treatment of relapsed or refractory classical Hodgkin lymphoma in children. Opdivo indicated as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT) and complete resection and indicated as adjuvant therapy in patients with muscle-invasive bladder carcinoma (MIBC) at a high risk of recurrence after undergoing radical resection. Opdivo in combination therapy with ipilimumab indicated in the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan for adult patients and in combination with cabozantinib as the first-line treatment in patients with advanced renal cell carcinoma and also in combination therapy with bevacizumab and chemotherapy as the first-line treatment in adult patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Opdivo is indicated as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.Nivolumab (ONO-4538) is under development for the treatment of unresectable anaplastic thyroid cancer, metastatic transitional (urothelial) tract cancer, neurofibromatosis type 1 (NF1), esophageal squamous cell carcinoma (ESCC), metastatic neuroendocrine prostate cancer (NEPC), craniopharyngioma, metastatic pancreatic cancer, advanced metastatic uveal melanoma, malignant peripheral nerve sheath tumors (MPNST), medullary thyroid carcinoma, duodenal cancer, gallbladder cancer, bile duct cancer, extrahepatic bile duct cancer, metastatic kirsten rat sarcoma positive (KRAS+) lung adenocarcinoma, neuroendocrine gastroenteropancreatic tumors, poorly-differentiated neuroendocrine carcinoma of pancreas, natural killer t-cell lymphomas, marginal zone lymphoma, advanced or metastativ squamous cell carcinoma of the skin, salivary gland cancer, penile cancer basaloid squamous cell carcinoma, neuroblastoma, relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma, renal cell carcinoma, homologous-recombination deficient (HRD) epithelial ovarian cancers including fallopian tube cancer and peritoneal cancer, lung adenocarcinoma, metastatic colorectal cancer, relapsed and refractory multiple myeloma, cutaneous melanoma, recurrent or metastatic squamous cell carcinoma of head and neck, nasopharyngeal carcinoma, newly diagnosed oral cavity squamous cell carcinoma, relapsed and refractory primary mediastinal B-cell lymphoma, oral leukoplakia, HPV-associated oropharynx squamous cell carcinoma, refractory metastatic squamous cell carcinoma of the anal canal, diffuse large B-cell lymphoma, unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer), chronic myelogenous leukemia, thymic carcinoma, small-cell lung cancer, pediatric Hodgkin lymphoma, virus-positive negative solid carcinoma, endometrial cancer, cervix cancer, chemo-refractory germ cell tumors, soft tissue sarcoma, sepsis, hepatocellular carcinoma, papillary renal cell carcinoma, relapsed or refractory follicular lymphoma, relapsed or refractory hematologic malignancy, B cell lymphoma, T cell lymphoma, peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) refractory/ relapsed acute myeloid leukemia, pediatric Hodgkin lymphoma, EBV-positive lymphoproliferative disorders like post-transplantation lymphoproliferative disorder, lymphomatoid granulomatosis, chronic leukemia, non-squamous non-small cell lung cancer and selected refractory or relapsed malignancies, pancreatic cancer, gastric cancer, neuroendocrine tumor, colon cancer, leiomyosarcoma, chondrosarcoma, osteosarcoma, pleomorphic liposarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (UPS/MFH), angiosarcoma, chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), urothelial cancer, triple negative breast cancer and metastatic castration-resistant prostate cancer (mCRPC), hepatitis C infection, metastatic pancreatic ductal adenocarcinoma, gorlin syndrome, undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, human papilloma virus infections and merkel cell cancer, relapsed/refractory primary central nervous system lymphoma (PCNSL) and relapsed/refractory primary testicular lymphoma, uterine body cancer and gastric cancer as adjuvant therapy. It is under development for the treatment of oral proliferative verrucous leukoplakia, signet-ring cell carcinoma, papillary adenocarcinoma, gastric or gastroesophageal junction (GEJ) cancers as first line, second line therapy, resected esophageal cancer (esophageal adenocarcinoma), diffuse intrinsic pontine glioma (DIPG), high grade glioma (HGG), medulloblastoma, ependymoma, meningioma, sezary syndrome, Mycosis fungoides and chordoma. It is under development as intrathecal injection for the treatment of leptomeningeal disease as intralesional injection for kaposi sarcoma. It is under development for the treatment of metastatic non-squamous NSCLC with and without the necessity of radiotherapy in 2nd-line or 3rd-line treatment. It is under development for epithelial ovarian cancer as third line therapy in combination with Oregovomab. It is under development for the treatment of muscle-invasive bladder cancer as second line therapy. It is under development for the treatment of hormone-sensitive prostate cancer as second line therapy. It is administered through intraperitonial route for the treatment of peritoneal cancer, cervical cancer and fallopian tube cancer as third line therapy. It was under development for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression = 1%, who are at high risk of recurrence after undergoing radical resection of MIUC. Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression = 1%. Opdivo (nivolumab) in combination with Yervoy as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is developed based on ENHANZE (recombinant human hyaluronidase PH20 enzyme (rHuPH20) Technology.It is also under development for the treatment of melanoma, lung, bladder, breast, ovarian, prostate cancers and sarcoma, extramammary paget disease (EMPD), squamous cell carcinoma, basal cell carcinoma (Basal Cell Epithelioma), intrahepatic or extrahepatic cholangiocarcinoma, gall bladder cancer and anaplastic astrocytoma.It was under development for rhabdomyosarcoma and low-grade glioma, biliary tract cancer, non-muscle invasive bladder 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 – Nivolumab LOA Data | |||||
Report Segments |
|
||||
Drug Name |
|
||||
Administration Pathway |
|
||||
Therapeutic Areas |
|
||||
Key Manufacturers |
|
||||
Drug Development Status |
|
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
This is an on-demand report that will be delivered upon request. The report will be delivered within 2 business days of the purchase, excluding weekends and holidays. Certain sections of the report may be removed or altered based on data availability and relevance.
Frequently asked questions
- Drugs which have been approved in the past 10 years
- Drugs which have failed during clinical development in the past 18 years
- Drugs which are currently in development
- Phase I, Phase II, Phase III, and Pre-Registration development stage
- Drugs must meet one of the following criteria to be included in the model:
- The developer has specified the US as an intended market for approval.
- The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”
- Innovator drugs and biosimilars
- Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
- Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
- Generic drugs
- Innovative drugs in Preclinical or Discovery Stage.
- Pipeline drugs sponsored by a Government or Institution.
- Drugs with a specific Drug Geography not the United States.
The probability of a drug ultimately receiving market authorization
The probability of a drug’s advancement to the next stage of clinical development
GlobalData’s Drug-Specific Likelihood of Approval (LoA) calculates the Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of Machine Learning (ML) and a GlobalData proprietary algorithm to process data points from the Drugs, Clinical Trials, Regulatory Milestones, Company, and Financial databases.
Inclusion
Data Scope:
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
Exclusion
Get in touch to find out about multi-purchase discounts
reportstore@globaldata.com
Tel +44 20 7947 2745