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Nivolumab - Bristol-Myers Squibb/Ono Pharmaceuticals

Drug Profile

Nivolumab - Bristol-Myers Squibb/Ono Pharmaceuticals

Alternative Names: BMS-936558; MDX-1106; Nivolumab BMS; ono-0123; ONO-4538; Opdivo

Latest Information Update: 14 Nov 2019

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At a glance

  • Originator Medarex; Ono Pharmaceutical
  • Developer Aduro BioTech; AIO Studien gGmbH; Alliance Foundation Trials; Australian and New Zealand Urogenital and Prostate Cancer Group; Barbara Ann Karmanos Cancer Institute; Bavarian Nordic; Big Ten Cancer Research Consortium; Bristol-Myers Squibb; Canadian Cancer Trials Group; Celleron Therapeutics; Clatterbridge Cancer Centre NHS Foundation Trust; Clovis Oncology; Curie Institute; Daiichi Sankyo Company; Dana-Farber Cancer Institute; Duke University Medical Center; Eisai Inc; Eli Lilly and Company; Emory University; European Thoracic Oncology Platform; Exelixis; Frontier Science foundation; Grupo Espanol Multidisciplinar de Melanoma; H. Lee Moffitt Cancer Center and Research Institute; Hoosier Cancer Research Network; HOVON Foundation; Incyte Corporation; Intergroupe Francophone de Cancerologie Thoracique; Janssen Biotech; Janssen Research & Development; Kansai Medical University; Kyoto Breast Cancer Research Network; M. D. Anderson Cancer Center; Massachusetts General Hospital; Medarex; Nantes University Hospital; National Cancer Center (Tokyo); National Cancer Centre (Singapore); National Cancer Institute (USA); Nektar Therapeutics; Neon Therapeutics; Netherlands Cancer Institute; Northwestern University; Ono Pharmaceutical; Pharmacyclics; PrECOG; Seattle Genetics; Sidney Kimmel Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Syneos Health; The University of Montreal Hospital Research Center; UNICANCER; University College London; University of Liverpool; University of Pittsburgh; University of Texas M. D. Anderson Cancer Center; Vanderbilt-Ingram Cancer Center; Zucero Therapeutics
  • Class Antineoplastics; Antivirals; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death-1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Mesothelioma; Malignant melanoma; Liver cancer; Hodgkin's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Colorectal cancer; Gastric cancer; Head and neck cancer; Hodgkin's disease; Malignant melanoma; Non-small cell lung cancer; Renal cell carcinoma; Urogenital cancer
  • Registered Liver cancer; Mesothelioma; Small cell lung cancer
  • Preregistration Oesophageal cancer
  • Phase III Bladder cancer; Breast cancer; Fallopian tube cancer; Glioblastoma; Multiple myeloma; Ovarian cancer; Peritoneal cancer
  • Phase II/III Non-Hodgkin's lymphoma
  • Phase II Acute myeloid leukaemia; Adrenocortical carcinoma; Biliary cancer; Brain metastases; Bronchopulmonary dysplasia; Cancer; Cervical cancer; Cholangiocarcinoma; Chronic lymphocytic leukaemia; CNS cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Genitourinary disorders; Leucoplakia; Liver metastases; Meningeal carcinomatosis; Myelodysplastic syndromes; Nasopharyngeal cancer; Oropharyngeal cancer; Pancreatic cancer; Penile cancer; Peripheral T-cell lymphoma; Prostate cancer; Soft tissue sarcoma; Solid tumours; Testicular cancer; Thyroid cancer; Uterine cancer; Uveal melanoma
  • Phase I/II Haematological malignancies; Lymphoma; Rectal cancer
  • Phase I Autoimmune disorders; Chronic myeloid leukaemia; Glioma; Hepatitis C; Sepsis

Most Recent Events

  • 14 Nov 2019 Planned Prescription Drug User Fee Act (PDUFA) date for Liver cancer (Second-line therapy or greater, Combination therapy, Metastatic disease, Late-stage disease) in USA (IV) is 2020-03-10
  • 13 Nov 2019 Bristol-Myers Squibb plans a phase I/II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater, Metastatic) in USA, Mexico, Puerto Rico (IV) (NCT04151563)
  • 12 Nov 2019 Preregistration for Liver cancer (Second-line therapy or greater, Combination therapy, Metastatic disease, Late-stage disease) in USA (IV)
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