Drug profile · INN
nivolumab
OPDIVO
nivolumab (OPDIVO) is a programmed cell death protein 1 inhibitor. Associated with Bristol-Myers Squibb Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.
Drug details — nivolumab
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- INJECTION
- Patents
- 2
- Programs
- 127
- Data quality
- 0.84
Quick answer
nivolumab (OPDIVO) is a programmed cell death protein 1 inhibitor. Associated with Bristol-Myers Squibb Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.
Key facts
Mechanism of action
Programmed cell death protein 1 inhibitor
Primary target: Programmed cell death protein 1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
| NMPA | clinical trials | — |
Recent coverage
Medicare price rule could hit Keytruda and Opdivo subcutaneous launches
CMS is proposing a Medicare drug price rule that could shape the outlook for subcutaneous Keytruda and Opdivo. The products are expected to be eligible for selection in the 2027 negotiation round for IPAY 2029.
Pharma bets on PD-1/VEGF bispecifics: Is lung cancer the wrong target?
While many drugmakers are focused on lung cancer for PD-1/VEGF bispecifics, emerging evidence shows the liver may offer higher value. This analysis covers the mechanism, key players, and strategic implications for pharma teams.
NMPA Approval Lung Cancer Immunotherapy: PD-1/PD-L1 Combo Trends 2025
This article delves into the NMPA's approval landscape for lung cancer immunotherapy, highlighting the emerging trends of PD-1/PD-L1 combination therapies by 2025.
FDA Approval VX-009: Market Analysis of Oncodex's Oncolytic Virus Therapy
Explore the implications of FDA-approved VX-009, Oncodex's groundbreaking oncolytic virus therapy, and its potential impact on the cancer treatment market.
Congress & event coverage
- PresentationESMO Gastrointestinal Cancers Congress
- PresentationPharma Manufacturing World
Pipeline programs
Related & competitor drugs
Related patents
Frequently asked questions
What is nivolumab?
nivolumab (OPDIVO) is a programmed cell death protein 1 inhibitor. Associated with Bristol-Myers Squibb Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.
What is the brand name for nivolumab?
OPDIVO is a marketed brand name for nivolumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of nivolumab?
nivolumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.