Pertuzumab
As of the edition of 20 October 2026, Pertuzumab is an antibody: marketed, first approved in 2012 (US); acts on ERBB2; US protection ended in 2024.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Antibody
- Brand name
- Perjeta
- First approved
- 8 June 2012 (US)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Roche; 5 holders in all
- Registered trials
- 267, 22 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Urinary and reproductive; Pregnancy and women's health; Hormones
US protection
US protection ended in 2024.
The reference-product exclusivity ended in 2024. The application that gives this date is held by Roche.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| ERBB2 | Receptor tyrosine-protein kinase erbB-2 | P04626 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 8 | 5 | 0 |
| Phase 1 | 25 | 13 | 5 | 5 |
| Phase 2 | 160 | 57 | 77 | 15 |
| Phase 3 | 57 | 22 | 29 | 2 |
| Phase 4 | 6 | 1 | 4 | 0 |
| All trials | 267 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2003 to now |