BMS-936558 (Nivolumab) — Competitive Intelligence Brief

BMS-936558 (Nivolumab) (BMS-936558 (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 Receptor-1) Oncology Biologic

Target snapshot

BMS-936558 (Nivolumab) (BMS-936558 (Nivolumab)) — Bristol-Myers Squibb. Nivolumab blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
BMS-936558 (Nivolumab) TARGET	BMS-936558 (Nivolumab)	Bristol-Myers Squibb	phase 3	PD-1 inhibitor	PD-1 (Programmed Death Receptor-1)
Keytruda	pembrolizumab	Merck & Co.	marketed	Monoclonal antibody; PD-1 inhibitor	PD-1 receptor	2014-09-04
Cemiplimab-Rwlc	Cemiplimab-Rwlc	H. Lee Moffitt Cancer Center and Research Institute	marketed	PD-1 inhibitor	PD-1
SOX plus PD-1 inhibitor	SOX plus PD-1 inhibitor	Liaoning Cancer Hospital & Institute	marketed	Chemotherapy + PD-1 inhibitor combination	PD-1 (programmed death receptor 1); S-1 (thymidylate synthase/5-FU metabolism); oxaliplatin (DNA cross-linking)
Tislelizumab + radiotherapy	Tislelizumab + radiotherapy	First Affiliated Hospital Xi'an Jiaotong University	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
Short-term Sintilimab	Short-term Sintilimab	Shanghai Jiao Tong University School of Medicine	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)

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