Drug Profile


Alternative Names: Anti-PD-1 monoclonal antibody - Medarex/Ono; BMS-936558; MDX-1106; Nivolumab BMS; ono-0123; ONO-4538; Opdivo

Latest Information Update: 16 Feb 2017

Price : $50

At a glance

  • Originator Medarex; Ono Pharmaceutical
  • Developer AIO Studien gGmbH; Bristol-Myers Squibb; Duke University Medical Center; Eli Lilly; Grupo Espanol Multidisciplinar de Melanoma; Incyte Corporation; Janssen Research & Development; Kyowa Hakko Kirin; Medarex; National Cancer Center (Tokyo); National Cancer Institute (USA); Nektar Therapeutics; Neon Therapeutics; Netherlands Cancer Institute; Ono Pharmaceutical; Pharmacyclics; Seattle Genetics; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Antivirals; Monoclonal antibodies
  • Mechanism of Action PDCD 1 protein inhibitors
  • Orphan Drug Status

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

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

Highest Development Phases

  • Marketed Malignant melanoma; Non-small cell lung cancer; Renal cell carcinoma
  • Registered Head and neck cancer; Hodgkin's disease; Urogenital cancer
  • Preregistration Gastric cancer
  • Phase III Glioblastoma; Hepatocellular carcinoma; Mesothelioma; Multiple myeloma; Oesophageal cancer; Ovarian cancer; Small cell lung cancer
  • Phase II Acute myeloid leukaemia; Breast cancer; Cancer; Cervical cancer; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Lymphoma; Myelodysplastic syndromes; Soft tissue sarcoma; Uterine cancer; Uveal melanoma
  • Phase I/II Colorectal cancer; Haematological malignancies; Non-Hodgkin's lymphoma; Rectal cancer; Solid tumours
  • Phase I Biliary cancer; Bladder cancer; Chronic myeloid leukaemia; Glioma; Hepatitis C

Most Recent Events

  • 08 Feb 2017 Bristol-Myers Squibb plans a phase I/II trial for Non-small cell lung cancer (Second-line therapy or greater, Late-stage disease, Combination therapy, Metastatic disease) (NCT03048136)
  • 07 Feb 2017 Bristol-Myers Squibb plans a phase III trial for Urogenital cancer in USA (NCT03036098)
  • 06 Feb 2017 Bristol-Myers Squibb completes an expanded-access programme for Melanoma (Combination therapy, Refractory, Metastatic disease) in USA and Canada (NCT02186249)
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