Treats HER2-positive, locally advanced, inflammatory, or early stage breast cancer…. BLA 761170, held by Genentech Inc. Pertuzumab, Trastuzumab, And Hyaluronidase-Zzxf.
As of Nov 14, 2026, BLA 761170 (Phesgo), held by Genentech Inc, was first approved by FDA on Jun 29, 2020, with 2 approved supplements and 0 published complete response letters.
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: Use 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.
| Nov 22, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2020 | Original applicationNew combination · Standard review | Approved |
| Phesgo1,200MG;600MG;30,000UNITS · injectable;subcutaneous | Pertuzumab, Trastuzumab, And Hyaluronidase-Zzxf | Rx |
| Phesgo600MG;600MG;20,000UNITS · injectable;subcutaneous | Pertuzumab, Trastuzumab, And Hyaluronidase-Zzxf | Rx |
| May 18, 2026 | Supplement 16Labeling · Standard review | Approved | |
| Nov 22, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2020 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
