Drug Type Biosimilar, Monoclonal antibody |
Synonyms EIRGASUN + [2] |
Target |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (15 Nov 2023), |
Regulation- |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Breast Cancer | LI | 15 Nov 2023 | |
HER2 Positive Breast Cancer | EU | 15 Nov 2023 | |
HER2 Positive Breast Cancer | IS | 15 Nov 2023 | |
HER2 Positive Breast Cancer | NO | 15 Nov 2023 | |
HER2-positive gastric cancer | IS | 15 Nov 2023 | |
HER2-positive gastric cancer | LI | 15 Nov 2023 | |
HER2-positive gastric cancer | EU | 15 Nov 2023 | |
HER2-positive gastric cancer | NO | 15 Nov 2023 | |
Metastatic breast cancer | IS | 15 Nov 2023 | |
Metastatic breast cancer | LI | 15 Nov 2023 | |
Metastatic breast cancer | EU | 15 Nov 2023 | |
Metastatic breast cancer | NO | 15 Nov 2023 | |
Metastatic Gastric Carcinoma | LI | 15 Nov 2023 | |
Metastatic Gastric Carcinoma | EU | 15 Nov 2023 | |
Metastatic Gastric Carcinoma | NO | 15 Nov 2023 | |
Metastatic Gastric Carcinoma | IS | 15 Nov 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 Positive Breast Cancer | Preclinical | - | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Preclinical | KR | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Preclinical | TW | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Preclinical | BY | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Preclinical | ZA | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Preclinical | CO | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Discovery | US | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Discovery | IN | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Discovery | UA | 16 Oct 2018 | |
HER2 Positive Breast Cancer | Discovery | CL | 16 Oct 2018 |
Phase 2 | 63 | ywmcbjglvb(cgcpdkgkdw) = rbninohbac koccykcdwr (ynkeivgeqv, hbfcknusbs - asaqpoxjqj) View more | - | 20 Dec 2012 | |||
Phase 3 | Advanced breast cancer First line | 303 | (edkzgqjlpy) = bhbznlvaky kuvkdgtexs (djicubyukw ) View more | Positive | 11 Apr 2017 | ||
(edkzgqjlpy) = hyratpzccf kuvkdgtexs (djicubyukw ) View more | |||||||
NCT01271920 (Pubmed) Manual | Phase 1/2 | 45 | (70 mg/m2) | (dvcfxcsopx) = the RP2D was weekly AUY922 70 mg/m2 plus trastuzumab ihtnftpitn (ozrlxkjvna ) | Positive | 21 Jun 2016 | |
Phase 1 | PIK3CA mutated/HER2 Positive Breast Cancer PIK3CA -Mutated | HER2-Positive | 21 | (daily alpelisib) | (hfbzmnhoav) = Grade ≥3 adverse events seen in ≥2 patients included diarrhea (n = 6), hypokalemia (n = 3), abnormal liver enzymes (n = 3), hyperglycemia (n = 2), mucositis (n = 2), and elevated lipase (n = 2).Grade ≥3 adverse events seen in ≥2 patients included diarrhea (n = 5), hypokalemia (n = 3), and hypomagnesemia (n = 2) whvmexngjh (tzpfnauvkg ) | Positive | 15 Jul 2021 | |
(intermittently dosed alpelisib) |