Who are FDA-licensed Nivolumab's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Keytruda, Tislelizumab + platinum-based chemotherapy, Nivolumab in combination with Ipilimumab, Tislelizumab + radiotherapy, Vevye®, Cemiplimab-Rwlc.

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Last reviewed 2026-06-10 · How we verify

FDA-licensed Nivolumab — Competitive Intelligence Brief

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA-licensed Nivolumab (FDA-licensed Nivolumab) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: PD-1 inhibitor. Area: Oncology.

phase 3 PD-1 inhibitor PD-1 (Programmed Death-1) Oncology Small molecule Live · refreshed every 30 min

Target snapshot

FDA-licensed Nivolumab (FDA-licensed Nivolumab) — Amgen. Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
FDA-licensed Nivolumab TARGET	FDA-licensed Nivolumab	Amgen	phase 3	PD-1 inhibitor	PD-1 (Programmed Death-1)
Keytruda	pembrolizumab	Merck & Co.	marketed	Monoclonal antibody; PD-1 inhibitor	PD-1 receptor	2014-09-04
Tislelizumab + platinum-based chemotherapy	Tislelizumab + platinum-based chemotherapy	Fujian Cancer Hospital	marketed	PD-1 inhibitor	PD-1
Nivolumab in combination with Ipilimumab	Nivolumab in combination with Ipilimumab	Bristol-Myers Squibb	marketed	Checkpoint inhibitor combination (PD-1 inhibitor + CTLA-4 inhibitor)	PD-1 and CTLA-4
Tislelizumab + radiotherapy	Tislelizumab + radiotherapy	First Affiliated Hospital Xi'an Jiaotong University	marketed	PD-1 inhibitor	PD-1
Vevye®	Vevye®	Baylor College of Medicine	marketed	PD-1 inhibitor	PD-1
Cemiplimab-Rwlc	Cemiplimab-Rwlc	H. Lee Moffitt Cancer Center and Research Institute	marketed	PD-1 inhibitor	PD-1

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (PD-1 inhibitor class)

Sun Yat-sen University · 11 drugs in this class
Bristol-Myers Squibb · 9 drugs in this class
Addpharma Inc. · 7 drugs in this class
Merck Sharp & Dohme LLC · 5 drugs in this class
Shanghai Henlius Biotech · 5 drugs in this class
Innovent Biologics (Suzhou) Co. Ltd. · 5 drugs in this class
Pfizer · 4 drugs in this class
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · 4 drugs in this class
Amgen · 3 drugs in this class
Daewoong Pharmaceutical Co. LTD. · 3 drugs in this class

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Cite this brief

Drug Landscape (2026). FDA-licensed Nivolumab — Competitive Intelligence Brief. https://druglandscape.com/ci/fda-licensed-nivolumab. Accessed 2026-06-10.

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