Shots: The P-III study evaluates the efficacy and safety of TX05 vs Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive early breast cancer The 1EPs was an […]readmore
Tags : HER2-Positive
Biotech
Regulatory
Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy
Shots: The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following […]readmore
Biosimilars
Regulatory
Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval
Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed […]readmore
Shots: The two companies divulged the results of ongoing P-II DESTINY-CRC01 study assessing Enhertu in patients with HER2+ unresectable and/or m-colorectal cancer, prior treated with 2L standard therapies. Results: ORR […]readmore
Biosimilars
Clinical Trials
Samsung Bioepis Reports Results of Ontruzant (biosimilar, trastuzumab) in P-III
Shots: The four-year follow-up data is part of the ongoing follow-up study, assessing the cardiac safety and survival outcome of Ontruzant vs Herceptin in a subgroup of patients from P-III […]readmore
Biosimilars
Regulatory
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, […]readmore
Regulatory
Roche’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) Receives FDA’s Approval for
Shots: The approval is based on three P-III study (HannaH, SafeHER, PrefHER) results assessing Herceptin Hylecta (SC) + CT vs Herceptin (IV) + CT in neoadjuvant and adjuvant patients with […]readmore
Shots: The P-III NALA Trial involves assessing of Neratinib + capecitabine vs Tykerb (lapatinib) + capecitabine in 621 patients in ratio (1:1) with HER2-Positive Metastatic Breast Cancer The P-III NALA Trial demonstrated improvement in […]readmore