Last reviewed 2026-04-23 · How we verify

FDA-licensed Nivolumab

Amgen · Phase 3 active Small molecule

FDA-licensed Nivolumab is a PD-1 inhibitor Small molecule drug developed by Amgen. It is currently in Phase 3 development for Metastatic non-small cell lung cancer, Metastatic melanoma, Advanced renal cell carcinoma. Also known as: OPDIVO®.

Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.

Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells. Used for Metastatic non-small cell lung cancer, Metastatic melanoma, Advanced renal cell carcinoma.

Likelihood of approval

64.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Big-pharma sponsor +3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	FDA-licensed Nivolumab
Also known as	OPDIVO®
Sponsor	Amgen
Drug class	PD-1 inhibitor
Target	PD-1 (Programmed Death-1)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Nivolumab is a monoclonal antibody that binds to programmed death receptor-1 (PD-1) on T cells, preventing interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and immune cells. This blockade releases the 'brakes' on the immune system, restoring T-cell proliferation, activation, and anti-tumor function. By reinvigorating exhausted T cells, nivolumab enables durable anti-tumor immunity.

Approved indications

Metastatic non-small cell lung cancer
Metastatic melanoma
Advanced renal cell carcinoma
Classical Hodgkin lymphoma
Squamous cell carcinoma of the head and neck
Urothelial carcinoma
Colorectal cancer (microsatellite instability-high or mismatch repair deficient)

Common side effects

Fatigue
Diarrhea
Nausea
Rash
Immune-mediated pneumonitis
Immune-mediated hepatitis
Immune-mediated colitis
Immune-mediated endocrinopathy

Key clinical trials

A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

FDA-licensed Nivolumab CI brief — competitive landscape report
FDA-licensed Nivolumab updates RSS · CI watch RSS
Amgen portfolio CI

Frequently asked questions about FDA-licensed Nivolumab

What is FDA-licensed Nivolumab?

FDA-licensed Nivolumab is a PD-1 inhibitor drug developed by Amgen, indicated for Metastatic non-small cell lung cancer, Metastatic melanoma, Advanced renal cell carcinoma.

How does FDA-licensed Nivolumab work?

Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.

What is FDA-licensed Nivolumab used for?

FDA-licensed Nivolumab is indicated for Metastatic non-small cell lung cancer, Metastatic melanoma, Advanced renal cell carcinoma, Classical Hodgkin lymphoma, Squamous cell carcinoma of the head and neck.

Who makes FDA-licensed Nivolumab?

FDA-licensed Nivolumab is developed by Amgen (see full Amgen pipeline at /company/amgen).

Is FDA-licensed Nivolumab also known as anything else?

FDA-licensed Nivolumab is also known as OPDIVO®.

What drug class is FDA-licensed Nivolumab in?

FDA-licensed Nivolumab belongs to the PD-1 inhibitor class. See all PD-1 inhibitor drugs at /class/pd-1-inhibitor.

What development phase is FDA-licensed Nivolumab in?

FDA-licensed Nivolumab is in Phase 3.

What are the side effects of FDA-licensed Nivolumab?

Common side effects of FDA-licensed Nivolumab include Fatigue, Diarrhea, Nausea, Rash, Immune-mediated pneumonitis, Immune-mediated hepatitis.

What does FDA-licensed Nivolumab target?

FDA-licensed Nivolumab targets PD-1 (Programmed Death-1) and is a PD-1 inhibitor.

Drug class: All PD-1 inhibitor drugs
Target: All drugs targeting PD-1 (Programmed Death-1)
Manufacturer: Amgen — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic non-small cell lung cancer
Indication: Drugs for Metastatic melanoma
Indication: Drugs for Advanced renal cell carcinoma
Also known as: OPDIVO®

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing