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Nivolumab · Opdivo, BMS-936558

Monoclonal antibody · Antagonist of PD-1 (PDCD1) · developed by Bristol Myers Squibb

Approved FDA, Dec 2014

BMY Developer

3 Registered trials

What is Nivolumab?

Nivolumab is a human IgG4 monoclonal antibody that binds to the PD-1 receptor on T cells and blocks its interaction with PD-L1 and PD-L2, releasing inhibition of the anti-tumor immune response.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Opdivo, BMS-936558, BMS-986298, MDX-1106
Drug type: Monoclonal antibody
Targets: PD-1 (PDCD1), PD-L1 (CD274) (secondary target), PD-L2 (PDCD1LG2) (secondary target)
Mechanism: Antagonist of PD-1 (PDCD1)
Pathways: T-cell proliferation, T-cell cytokine production, anti-tumor immune response
Therapy area: Oncology
Developer: Bristol Myers Squibb (BMY)
FDA status: Approved as Opdivo (December 22, 2014), BLA125554 · FDA label
UNII: 31YO63LBSN

✅ FDA-approved uses

Unresectable or metastatic melanoma
Adjuvant treatment of completely resected Stage IIB, IIC, III, or IV melanoma
Resectable non-small cell lung cancer in the neoadjuvant setting
Metastatic non-small cell lung cancer
Unresectable malignant pleural mesothelioma
Intermediate or poor risk advanced renal cell carcinoma

From the indications section of the FDA label (version of Aug 12, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06561386	Phase 3	Non-small Cell Lung Cancer	Recruiting	BMY
NCT04396821	Phase 1/2	Advanced Cancer	Active not recruiting	BMY
NCT02693535	Phase 2	Lymphoma, Non-Hodgkin	Recruiting	BMY

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Advanced CancerAdvanced Solid TumorsGastric CancerGastroesophageal-junction CancerLymphoma, Non-HodgkinMultiple MyelomaNon-small Cell Lung CancerPancreatic Cancer

Other drugs acting on PDCD1

Berahyaluronidase Alfa and Pembrolizumab FDA approved Pembrolizumab FDA approved Toripalimab FDA approved Atigotatug/Nivolumab Phase 1 Balstilimab Phase 2/3 BPT567 Phase 1 Budigalimab Phase 2/3 Cadonilimab Early Phase 1 CDX-585 Phase 1 CTX-8371 Phase 1 Geptanolimab Phase 1/2 Ivonescimab Phase 3

More from Bristol Myers Squibb

Apixaban FDA approved Belatacept FDA approved Deucravacitinib FDA approved Ipilimumab FDA approved Lisocabtagene Maraleucel FDA approved Luspatercept FDA approved Mavacamten FDA approved Nab-paclitaxel FDA approved Ozanimod FDA approved Relatlimab FDA approved Repotrectinib FDA approved Xanomeline FDA approved

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BMY page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z