Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 99 |
| INN | Nivolumab |
| Status | Approved |
| Drug code(s) | MDX-1106, ONO-4538, BMS-936558 |
| Brand name | OPDIVO |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab) |
| Target(s) | PD-1 |
| Indications of clinical studies | Renal Cell Carcinoma, Malignant Melanoma, Non-small Cell Lung Cancer, Prostrate Cancer, hematologic malignancy, Hepatitis C |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 27, 2006 |
| Start of Phase 2 | May 15, 2011 |
| Start of Phase 3 | October 15, 2012 |
| Date BLA/NDA submitted to FDA | July 30, 2014 |
| Year of first approval (global) | 2014 |
| Date of first US approval | December 22, 2014 |
| INN, US product name | Nivolumab |
| US or EU approved indications | Melanoma, non-small-cell lung cancer, Renal Cell Cancer, Hepatocellular Cancer (Including Secondary Metastases), Colorectal Cancer, Hodgkin's Lymphoma, Head and Neck Cancer, Bladder Cancer, intermediate- and poor-risk advanced renal cell carcinoma in a first-line setting. In 2018, the combination of Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). |
| Company | Bristol-Myers Squibb |
| Licensee/Partner | Ono |
| Comments about company or candidate | Jan 2021: In consultation with the FDA, Bristol Myers Squibb has decided to withdraw nivolumab (Opdivo) from the United States market for the treatment of patients with small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy and at least 1 other line of therapy. Approved in Japan July 4, 2014 Approved in US for melanoma Dec 22, 2014, and March 4, 2015 for non-small cell lung cancer. Marketing application filed in Japan as of 12/24/2013 for melanoma; mAb has orphan desig. In Japan for melanoma. Fast Track designation for nivolumab in three tumor types: non-small-cell lung cancer, renal cell carcinoma and advanced melanoma; Breakthrough Therapy designation for Hodgkin lymphoma. June 2016: A breakthrough therapy designation from the FDA was granted to Bristol-Myers Squibb's Opdivo, or nivolumab, for the treatment of patients with metastatic urothelial carcinoma whose condition progressed during or after a platinum-based chemotherapy |
| Full address of company | Route 206 & Province Line Road Princeton, New Jersey 08543 North America United States of America https://www.bms.com/about-us/contact-us.html |
Immune checkpoint target. Hinge stabilized IgG4 (S228P) with no ADCC and CDC activity
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |