GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2020)
Roche Holding AG · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Genentech's Perjeta (pertuzumab) for HER2-positive breast cancer, converting its accelerated neoadjuvant approval to regular approval and expanding its use to adjuvant therapy. This decision was based on robust clinical trial data, primarily from the APHINITY study, which demonstrated significant improvements in Invasive Disease-Free Survival (IDFS) in early breast cancer. Other trials (CLEOPATRA, NeoSphere, TRYPHAENA, BERENICE) supported its efficacy in metastatic and neoadjuvant settings, showing improved progression-free survival, overall survival, and pathological complete response rates. While effective, Perjeta's safety profile includes warnings for left ventricular dysfunction and embryo-fetal toxicity, with common adverse reactions like diarrhea, neutropenia, and infusion-related reactions. The report details comprehensive safety analyses, including cardiac events and adverse events across various subgroups, and outlines dosage, administration, and regulatory discussions.
Key findings — cited to the page
| Increased incidence of decreased appetite (all grade) | 13% | · p.33 |
| Increased incidence of hypomagnesemia (all grade) | 5% | · p.33 |
| Febrile neutropenia (Grade 3-4) | 13% | · p.33 |
| Febrile neutropenia (Grade 3-4) | 12% | · p.33 |
| Diarrhea (Grade 3-4) | 17% | · p.33 |
| Anemia (Grade 3-4) | 15% | · p.33 |
| SAEs of any grade in Cohort B (BERENICE) | 52 | BERENICE · p.144 |
| SAEs of any grade in Cohort A (BERENICE) | 45 | BERENICE · p.144 |
| Neutropenia (Grade 3-4) | 22% | · p.33 |
| Neutropenia (Grade 3-4) | 23% | · p.33 |
| Diarrhea (Grade 3-4) | 15% | · p.33 |
| Increased incidence of anemia (all grade) | 7% | · p.33 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →