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Association details:
| Biomarker: | HER-2 overexpression |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Ogivri (trastuzumab-dkst) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Health Canada Approves Biocon and Mylan’s Ogivri™, the First Trastuzumab Biosimilar, for the Treatment of HER2-Positive Breast and Gastric Cancers
Published date:
05/22/2019
Excerpt:
Biocon Ltd. and Mylan N.V. today announced that Health Canada has approved Mylan’s Ogivri™ (trastuzumab), a biosimilar to Herceptin1 (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
Source:
Published date:
12/12/2018
Excerpt:
Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):...in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable...in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease...in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin....in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter....Ogivri should only be used in patients with metastatic or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Secondary therapy:
bisphosphonate bound paclitaxel; carboplatin + docetaxel; Chemotherapy; docetaxel
Source:
Title:
Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin©+ Taxane for 1st Line, Met. Br. Ca.
Excerpt:
...Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization....
Trial ID:
