Perjeta(pertuzumab)
Oncology· 4060 cited findings· 6 source documents
Company: Roche Holding AG →
What the regulatory reviews say
Perjeta (pertuzumab) is an antineoplastic agent, a monoclonal antibody (L01XC13), developed by Roche Registration Ltd. It is provided as a concentrate for solution for infusion, with a strength of 420 mg. Perjeta received an authorization recommendation in December 2012.
Perjeta is approved for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer. This indication applies to patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Key efficacy findings include a progression-free survival (PFS) hazard ratio of 0.62 (95% CI: 0.51, 0.75; p-value < 0.0001), representing a 38% PFS improvement. The median PFS was 18.5 months, compared to 12.4 months in the control arm. The overall survival (OS) hazard ratio was 0.66, with a median OS of 56.5 months, compared to 40.8 months in the control arm, indicating a 15.7 months OS improvement. The incidence of serious adverse events (SAEs) ranged from 29.0% to 36.3%.
Key figures — cited to the source page
| PFS Hazard Ratio | 0.62 | Roche Holding AG — Perjeta EMA EPAR public assessment report, p.3 |
| PFS 95% CI | 0.51, 0.75 | Roche Holding AG — Perjeta EMA EPAR public assessment report, p.3 |
| PFS improvement | 38 | Roche Holding AG — Perjeta EMA EPAR public assessment report, p.3 |
| Overall Survival Hazard Ratio | 0.66 | Roche Holding AG — Perjeta EMA EPAR public assessment report, p.3 |
| overall survival (OS) improvement | 15.7 | Roche Holding AG — Perjeta EMA EPAR variation assessment rep, p.55 |
| incidence of SAEs | 36.3 | Roche Holding AG — Perjeta EMA EPAR variation assessment rep, p.78 |
| Strength | 420 | Roche Holding AG — Perjeta EMA EPAR public assessment report, p.4 |
| Authorization recommendation date | December 2012 | Roche Holding AG — Perjeta EMA EPAR public assessment report, p.2 |
Source documents
- GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2021) (2021)
- GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2020) (2020)
- GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2020) (2020)
- Roche Holding AG — Perjeta EMA EPAR public assessment report (EMEA/H/C/002547, 2013) (2013)
- Roche Holding AG — Perjeta EMA EPAR variation assessment report (EMEA/H/C/002547, 2013) (2013)
- Roche Holding AG — Perjeta EMA EPAR variation assessment report (EMEA/H/C/002547, 2013) (2013)
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.