Nivolumab is under clinical development by Bristol-Myers Squibb and currently in Phase II for Metastatic Adenocarcinoma of The Pancreas. According to GlobalData, Phase II drugs for Metastatic Adenocarcinoma of The Pancreas have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Nivolumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Nivolumab overview

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. 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).

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 Nivolumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 15 September 2023

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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.