Tags : breast

Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval

Shots: The approval is based on study assessing Ogivri vs Herceptin (trastuzumab) in patients evaluating its safety, efficacy, PK and immunogenicity The study resulted with no clinical difference in safety, efficacy and potency between Ogivri and Herceptin Ogivri (trastuzumab, biosimilar) is a mAb, currently approved in 65 countries including the US. Ogivri is one of […]Read More

Roche Launches Ventana HER2 Dual ISH CDx for the Identification

 Shots: Roche’s Ventana HER2 Dual ISH DNA Probe Cocktail assay is used to detect HER2 biomarker in breast and gastric cancer patients receiving Herceptin (trastuzumab) The approval of Ventana HER2 Dual ISH assay supports Roche’s personalized healthcare sector by providing techniques to diagnose breast and gastric cancer The Ventana HER2 assay is fully automated on […]Read More

Samsung Bioepis’ Biosimilar Transtuzumab Ontruzant (transtuzumab,dttb), Receives US FDA Approval

Shots: The US FDA has approved Ontruzant for all eligible indication vs reference Herceptin(transtuzumab), for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients not received prior treatment for metastatic disease The approval is based on clinical study results assessing Ontruzant vs Herceptin in 367 […]Read More