Dinutuximab
Approved · EMAAlso known as Unituxin, CHIMERIC ANTI-DISIALOGANGLIOSIDE (GD2) MONOCLONAL ANTIBODY (CH14.18/CHO), IMMUNOGLOBULIN G1, ANTI-(GANGLIOSIDE GD2) (HUMAN-MUS MUSCULUS MONOCLONAL CH14.18 HEAVY CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL CH14.18 LIGHT CHAIN, DIMER, IMMUNOGLOBULIN G1, ANTI-(GANGLIOSIDE GD2) (HUMAN-MUS MUSCULUS MONOCLONAL CH14.18/CHO HEAVY CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL CH14.18/CHO LIGHT CHAIN, DIMER.
Recent clinical, regulatory, research and industry developments relating to this drug.
Approval: Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (EMA)
Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma.
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: Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior… Show full indicationShow less
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.
Indication: Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a… Show full indicationShow less
Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin 2 (IL 2).
Indication: Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma… Show full indicationShow less
Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate. Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5?fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Non-small cell lung cancer Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy. Hepatocellular carcinoma Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ? 400 ng/ml and who have been previously treated with sorafenib.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
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 themes1
Journals, researchers & institutions
- The New England journal of medicine1
- Anderson B1
- Buxton A1
- Chen HX1
- Cohn SL1
- Gillies SD1
- Gilman AL1
- Grupp SA1
- Kreissman SG1
- University of California1
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 the same disease area as Dinutuximab in the shared literature.
Studied across the same disease area as Dinutuximab in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.