Roche Holding AG — Phesgo EMA EPAR public assessment report (EMEA/H/C/005386, 2020)
Roche Holding AG · 2020 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's public assessment report for Phesgo (pertuzumab/trastuzumab) details its approval as a fixed-dose subcutaneous combination for HER2-positive early and metastatic breast cancer. Developed by Roche, Phesgo offers a less invasive alternative to intravenous infusions. Pharmaceutical development confirmed product stability and an 18-month shelf-life. Non-clinical and pharmacokinetic studies, including the pivotal Phase III FeDeriCa trial, demonstrated non-inferiority of Phesgo's pharmacokinetics compared to IV formulations, with comparable efficacy (total pathological complete response) and safety profiles. Adverse events, primarily chemotherapy-related, were similar across administration routes. The benefit-risk balance was deemed positive, leading to marketing authorization.
Key findings — cited to the page
| Grade 3-4 AEs: White blood cell count decreased (Overall) | 19 (7.5%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: White blood cell count decreased (Overall) | 10 (4.0%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Neutrophil count decreased (Overall) | 33 (13.1%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Diarrhoea (Overall) | 18 (7.3%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Febrile neutropenia (Overall) | 14 (5.6%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Febrile neutropenia (Overall) | 16 (6.5%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Neutropenia (Overall) | 35 (13.9%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Neutropenia (Overall) | 36 (14.5%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Neutrophil count decreased (Overall) | 27 (10.9%) | FeDeriCa study · p.87 |
| Grade 3-4 AEs: Diarrhoea (Overall) | 13 (5.2%) | FeDeriCa study · p.87 |
| High-grade AEs in adjuvant phase (IV arm) | 15 % | FeDeriCa · p.100 |
| High-grade AEs in adjuvant phase (SC arm) | 11 % | FeDeriCa · p.100 |
Source: Roche Holding AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →