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Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer later that year. [8] Results of a Phase II trial in the neoadjuvant setting, NeoSphere, published in 2012, [ 22 ] and results of a Phase II cardiac safety study in the same population, Tryphaena, published in 2013. [ 23 ]
FDA Grants Genentech's Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer The Perjeta regimen is the first treatment approved under a new ...
The fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase was approved for medical use in the United States in June 2020. [5] [10]The FDA's approval was based on the results of a non-inferiority study in participants with HER2-positive early breast cancer, which demonstrated the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase had comparable efficacy and ...
FDA Advisory Committee Recommends Accelerated Approval of Genentech's Perjeta for Neoadjuvant Use in HER2-Positive Early Stage Breast Cancer The FDA Will Make a Final Decision by October 31 The ...
Roche (RHHBY) receives FDA approval for a fixed-dose combination of Perjeta and Herceptin, Phesgo, plus chemotherapy as a treatment for HER2-positive breast cancer.
1982: Synthetic "human" insulin approved by the U.S. Food and Drug Administration (FDA), partnered with insulin manufacturer Eli Lilly and Company, who shepherded the product through the FDA approval process. The product was licensed to and manufactured by Lilly, and was the first-ever approved genetically engineered human therapeutic.
FDA Grants Genentech's Perjeta Regimen Priority Review for Use Before Surgery in HER2-Positive Early Stage Breast Cancer Application follows proposed new FDA pathway designed to help bring ...
In 2013, trastuzumab emtansine was approved in the United States for the treatment of adults with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. [18] [20] Referred to as T-DM1 during clinical research, trastuzumab emtansine was reviewed under the FDA's priority review ...