Roche Holding AG — Perjeta EMA EPAR variation assessment report (EMEA/H/C/002547, 2013)
Roche Holding AG · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer, based on the APHINITY Phase III study. The study, involving 4805 patients, demonstrated a statistically significant improvement in invasive disease-free survival (IDFS) with pertuzumab, trastuzumab, and chemotherapy, particularly in high-risk subgroups like node-positive patients. While overall survival data remained immature, the efficacy benefit was deemed clinically relevant. Pharmacokinetic analysis showed no impact of trastuzumab on pertuzumab exposure. Safety concerns included higher rates of Grade 3-5 adverse events, especially diarrhea, and increased cardiac events in the pertuzumab arm, though these were considered manageable. The report details various adverse events, their management, and the overall safety profile, concluding with the CHMP's positive assessment for the extended indication.
Key findings — cited to the page
| Syncope events considered related to HER2-targeted treatment (Grade ≥ 3) in Pla+H+Chemo arm | 3 patients | · p.82 |
| Syncope events considered related to HER2-targeted treatment (Grade ≥ 3) in Ptz+H+Chemo arm | 3 patients | · p.82 |
| Syncope events considered related to HER2-targeted treatment (All Grades) in Ptz+H+Chemo arm | 4 patients | · p.82 |
| Syncope events considered related to HER2-targeted treatment (All Grades) in Pla+H+Chemo arm | 3 patients | · p.82 |
| Arthralgia (IRR) | 182 patients | · p.85 |
| Arthralgia (IRR) | 213 patients | · p.85 |
| Hot flush (IRR) | 157 patients | · p.85 |
| incidence of Grade ≥ 3 diarrhea | 3.7 % | APHINITY · p.18 |
| incidence of Grade ≥ 3 AEs (any AE) | 57.3 % | APHINITY · p.18 |
| incidence of Grade ≥ 3 AEs (any AE) | 64.25 % | APHINITY · p.18 |
| incidence of Grade ≥ 3 diarrhea | 9.9 % | APHINITY · p.18 |
| Hot flush (IRR) | 148 patients | · p.85 |
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 →