Drugs / Phesgo
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PHESGO | — | 2024-11-22 | fda.gov ↗ |
| Approved | EU (EMA) | Phesgo | — | 2020-12-21 | europa.eu ↗ |
| Approved | US (FDA) | PHESGO | — | 2020-06-29 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT06068985 | Sep 2024 → Apr 2026 overdue | HER2 positive breast carcinoma | Latin American Cooperative Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06439693 | Aug 2024 → Mar 2030 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, female breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05296798 | Jul 2022 → Jun 2028 expected | breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT05593094 Background | Sep 2020 → Aug 2027 expected | HER2 positive breast carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05306041 Background | Jan 2023 → Jan 2027 expected | HER2 positive breast carcinoma | GBG Forschungs GmbH | Recruiting | No outcome recorded |
| Phase 3 | NCT05894239 Background | Sep 2023 → Dec 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-04-30 | Hoffmann-La Roche | Regulatory CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings roche.com ↗ |
| 2020-12-23 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer. |
| 2020-11-13 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer roche.com ↗ |
| 2020-09-17 | Hoffmann-La Roche | Results Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020 roche.com ↗
Data from the phase II PHranceSCa study show the majority of patients prefer treatment with Phesgo™, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), compared to standard intravenous formulations. |
| 2020-06-29 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer roche.com ↗ |
All press releases naming this drug 5 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Phesgo | “Phesgo used outside of indication, based on biomarkers.” NCT04817956 ↗ |
| Action | Inhibit | “dual anti-HER2 blockade” NCT05306041 ↗ |
| Route | Subcutaneous | “Phesgo will be administered subcutaneously (SC)” NCT05296798 ↗ |