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 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04802759 | Jun 2021 → May 2029 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| 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 → Oct 2027 expected | breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05593094 Background | Sep 2020 → Aug 2027 expected | HER2 positive breast carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05306041 Background | Jan 2023 → Oct 2026 expected | HER2 positive breast carcinoma | GBG Forschungs GmbH | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05894239 Background | Sep 2023 → Dec 2026 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-30 | Roche Global Development | CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings roche.com ↗ |
| 2020-12-23 | Roche Global Development | 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 ↗ |
| 2020-11-13 | Roche Global Development | 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 ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Phesgo | “Phesgo used outside of indication, based on biomarkers.” NCT04817956 ↗ |
| Known as | PH FDC SC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04802759 ↗ |
| Action | Inhibit | “dual anti-HER2 blockade” NCT05306041 ↗ |
| Route | Subcutaneous | “will be administered SC” NCT04802759 ↗ |