Pertuzumab and Trastuzumab hyaluronidase (Phesgo)

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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