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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.
Roche's (RHHBY) new fixed-dose combination of Perjeta and Herceptin meets the primary endpoint in the phase III study for treating patients with HER2-positive early breast cancer.
Pertuzumab, sold under the brand name Perjeta, is a monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer.
Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. [31] [28] [32] [33] It is specifically used for cancer that is HER2 receptor positive. [31] It may be used by itself or together with other chemotherapy medication. [31]
Clinical trial number NCT01566721 for "A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (SafeHER)" at ClinicalTrials.gov
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 ...
HER2 is the target of the monoclonal antibody trastuzumab (marketed as Herceptin). Trastuzumab is effective only in cancers where HER2 is over-expressed. One year of trastuzumab therapy is recommended for all patients with HER2-positive breast cancer who are also receiving chemotherapy. [33]
Herceptin: This is Roche's wonder drug, approved in 1998 for patients with HER2-positive metastatic breast cancer and responsible for $4.8 billion in global sales in 2011. As you probably inferred ...