Difference between revisions of "Pertuzumab and Trastuzumab hyaluronidase (Phesgo)"
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Latest revision as of 04:00, 1 June 2024
General information
A combination of pertuzumab and trastuzumab, to be given by subcutaneous injection
Diseases for which it is established
History of changes in FDA indication
- 2020-06-29: Initial approval in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (Based on NeoSphere, TRYPHAENA, BERENICE, APHINITY, FeDeriCa)
- 2020-06-29: Initial approval in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. (Based on NeoSphere, TRYPHAENA, BERENICE, APHINITY, FeDeriCa)
- 2020-06-29: Initial approval in combination with docetaxel for treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (Based on CLEOPATRA & FeDeriCa)
History of changes in EMA indication
- 2020-12-21: Initial authorization
History of changes in PMDA indication
- 2023-09-25: New combination drugs with a new active ingredient indicated for the treatment of HER2-positive breast cancer.
- 2023-09-25: New combination drugs with a new active ingredient indicated for the treatment of unresectable advanced or recurrent HER2-positive colon or rectal cancer that has progressed after cancer chemotherapy.
Also known as
- Generic name: pertuzumab/trastuzumab/hyaluronidase-zzxf
- Brand name: Phesgo