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: 27 Mar 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Malignant melanoma; Non-small cell lung cancer; Renal cell carcinoma
  • 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; Carcinomatous meningitis; 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 Bladder cancer; Colorectal cancer; Haematological malignancies; Non-Hodgkin's lymphoma; Rectal cancer; Solid tumours
  • Phase I Biliary cancer; Chronic myeloid leukaemia; Glioma; Hepatitis C

Most Recent Events

  • 13 Mar 2017 Bristol-Myers Squibb amends the clinical trial protocol for phase I/II trial in Solid tumours (Combination Therapy)
  • 09 Mar 2017 Bristol-Myers Squibb terminates a phase I/II trial for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in USA, Finland due to lack of efficacy in the short term acute phase (NCT02472977)
  • 06 Mar 2017 Bristol-Myers Squibb plans a phase III trial for Melanoma (Late-stage disease, Combination therapy, Monotherapy therapy) in USA, Australia, Belgium, Czech Republic, Hungary, Italy, New Zealand, Poland, Romania, Spain and United Kingdom (NCT03068455)
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