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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 ]
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 ...
Randomization was stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease. [16] The FDA approved trastuzumab deruxtecan for the treatment of HER2-low breast cancer based on DESTINY-Breast04, a randomized, multicenter, open label clinical trial that enrolled 557 adult participants with unresectable ...
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 ...
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 ...
It's been a long time coming but Roche and ImmunoGen's breast cancer drug T-DM1 is finally approved for sale in the U.S., with a new name, Kadcyla, to boot. You'll recall -- or maybe you won't if ...
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 ...
The therapy, Phesgo, was approved for patients with HER2-positive breast cancer and comes with a boxed warning flagging risks of potential heart failure, fetal harm and lung toxicity. The ...