Ipilimumab
Approved · FDA / EMAAlso known as Yervoy.
Recent clinical, regulatory, research and industry developments relating to this drug.
DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial
Label change: IPILIMUMAB (BLA125377)
Indication expansion: IPILIMUMAB (BLA125377)
Indication expansion: IPILIMUMAB (BLA125377)
Indication expansion: IPILIMUMAB (BLA125377)
Neoadjuvant Immunotherapy in Locally Advanced Mismatch Repair-Deficient Colon Cancer.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of… Show full indicationShow less
Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC) Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- The New England journal of medicine6
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology3
- Journal of immunotherapy (Hagerstown, Md. : 1997)2
- Nature communications2
- International journal of radiation oncology, biology, physics1
- JAMA oncology1
- Ascierto PA7
- Hodi FS7
- Dummer R6
- Maio M6
- Wolchok JD6
- Chiarion-Sileni V5
- Ferrucci PF5
- Grob JJ5
- Aix-Marseille University2
- Center for Cancer Research2
- City of Hope Comprehensive Cancer Center2
- Netherlands Cancer Institute2
- The Netherlands Cancer Institute2
- University Hospitals Leuven2
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across 4 of the same disease areas as Ipilimumab in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.