FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer


29 June 2020 - Today the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (Phesgo, Genentech) for subcutaneous injection for the following indications:

Use in combination with chemotherapy as:

  • Neo-adjuvant 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
  • Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence
  • Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Efficacy was investigated in FeDeriCa, an open-label, multicenter, randomised trial enrolling 500 patients with operable or locally advanced HER2-positive breast cancer. Patients were randomised to receive neo-adjuvant chemotherapy with concurrent administration of either PHESGO or intravenous pertuzumab and intravenous trastuzumab during the neo-adjuvant and adjuvant therapies.

Read FDA press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US