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Nivolumab - Bristol-Myers Squibb/Ono Pharmaceuticals

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Drug Profile

Nivolumab - Bristol-Myers Squibb/Ono Pharmaceuticals

Alternative Names: BMS-936558; BMS-936558-01; MDX-1106; NIVO; Nivolumab BMS; ono-0123; ONO-4538; Opdivo

Latest Information Update: 24 May 2024

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At a glance

  • Originator Medarex; Ono Pharmaceutical
  • Developer Aduro BioTech; Agios Pharmaceuticals; AIO Studien gGmbH; Alliance Foundation Trials; Amgen; Australian and New Zealand Urogenital and Prostate Cancer Group; Barbara Ann Karmanos Cancer Institute; Bavarian Nordic; Big Ten Cancer Research Consortium; Bristol-Myers Squibb; Calithera Biosciences; Canadian Cancer Trials Group; CanBas; Cancer Research Institute; Celgene Corporation; Clatterbridge Cancer Centre NHS Foundation Trust; Clovis Oncology; Compugen; Curie Institute; Daiichi Sankyo Company; Dana-Farber Cancer Institute; Eisai Inc; Eli Lilly and Company; Emory University; European Thoracic Oncology Platform; Exelixis; F-star Therapeutics; Frontier Science foundation; Grupo Espanol Multidisciplinar de Melanoma; H. Lee Moffitt Cancer Center and Research Institute; Hoosier Cancer Research Network; HOVON Foundation; Icahn School of Medicine at Mount Sinai; Incyte Corporation; IngenOx Therapeutics; Intergroupe Francophone de Cancerologie Thoracique; Janssen Biotech; Janssen Research & Development; Jazz Pharmaceuticals Inc; Kansai Medical University; Kyoto Breast Cancer Research Network; M. D. Anderson Cancer Center; Massachusetts General Hospital; Medarex; Memorial Sloan-Kettering Cancer Center; Nantes University Hospital; National Cancer Center (Tokyo); National Cancer Centre (Singapore); National Cancer Institute (USA); National Institute of Neurological Disorders and Stroke; Nektar Therapeutics; Neon Therapeutics; Netherlands Cancer Institute; Northwestern University; Novartis; Ono Pharmaceutical; Oslo University Hospital; Parker Institute for Cancer Immunotherapy; Pharmacyclics; PrECOG; Seagen; Sidney Kimmel Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Syneos Health; TARIS Biomedical; The University of Montreal Hospital Research Center; UNICANCER; University College London; University of Liverpool; University of Pittsburgh Medical Center; 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; Gastric cancer; Liver cancer; Hodgkin's disease; Cancer; Oesophageal cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Colorectal cancer; Gastric cancer; Head and neck cancer; Hodgkin's disease; Liver cancer; Malignant melanoma; Mesothelioma; Non-small cell lung cancer; Oesophageal cancer; Renal cell carcinoma; Squamous cell cancer; Urogenital cancer
  • Registered Cancer; Small cell lung cancer
  • Phase III Bladder cancer; Breast cancer; Fallopian tube cancer; Glioblastoma; Multiple myeloma; Ovarian cancer; Peritoneal cancer; Prostate cancer
  • Phase II/III Non-Hodgkin's lymphoma
  • Phase II Acute myeloid leukaemia; Adrenocortical carcinoma; Alveolar soft part sarcoma; Biliary cancer; Brain metastases; Bronchopulmonary dysplasia; Cervical cancer; Cholangiocarcinoma; Chronic lymphocytic leukaemia; Clear cell sarcoma; CNS cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Gastrointestinal stromal tumours; Genitourinary disorders; Glioma; Gynaecological cancer; Leucoplakia; Liver metastases; Meningeal carcinomatosis; Myelodysplastic syndromes; Nasopharyngeal cancer; Pancreatic cancer; Penile cancer; Peripheral T-cell lymphoma; Soft tissue sarcoma; Solid tumours; Testicular cancer; Thyroid cancer; Uterine cancer; Uveal melanoma
  • Phase I/II Haematological malignancies; Rectal cancer
  • Phase I Autoimmune disorders; Hepatitis B; Hepatitis D; Neurofibrosarcoma
  • No development reported Chronic myeloid leukaemia; Hepatitis C; Sepsis

Most Recent Events

  • 21 May 2024 FDA assigns PDUFA action date of 29/12/2024 for nivolumab for Solid tumours (SC)
  • 06 May 2024 US FDA accepts BLA for the nivolumab for all approved adult solid tumor indications for review .
  • 26 Apr 2024 Bristol Myers Squibb anticipates the final EC decision on the approval of nivolumab for Urogenital cancer in June 2024
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