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  2. Pertuzumab - Wikipedia

    en.wikipedia.org/wiki/Pertuzumab

    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 ]

  3. Pertuzumab/trastuzumab/hyaluronidase - Wikipedia

    en.wikipedia.org/wiki/Pertuzumab/trastuzumab/...

    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 ...

  4. Trastuzumab deruxtecan - Wikipedia

    en.wikipedia.org/wiki/Trastuzumab_deruxtecan

    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 ...

  5. FDA Grants Genentech's Perjeta Accelerated Approval for ... - AOL

    www.aol.com/news/2013-09-30-fda-grants-genen...

    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 ...

  6. FDA Advisory Committee Recommends Accelerated Approval of ...

    www.aol.com/news/2013-09-12-fda-advisory...

    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 ...

  7. Finally Approved! Now, About Those Sales... - AOL

    www.aol.com/news/2013-02-22-finally-approved-now...

    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 ...

  8. Trastuzumab emtansine - Wikipedia

    en.wikipedia.org/wiki/Trastuzumab_emtansine

    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 ...

  9. Roche's combo therapy for advanced breast cancer gets U.S ...

    www.aol.com/news/roches-combo-therapy-advanced...

    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 ...