GENENTECH — Perjeta FDA Review (NDA/BLA 125409, 2021)
Roche Holding AG · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA's review and approval of Genentech's supplemental Biologics License Applications (sBLA) for Perjeta (pertuzumab). Key updates include changes to the 'USE IN SPECIFIC POPULATIONS' section and compliance with the Pregnancy and Lactation Labeling Rule (PLLR), leading to a Boxed Warning for embryo-fetal toxicity. The report details Perjeta's efficacy and safety in combination therapies for HER2-positive metastatic and neoadjuvant breast cancer, highlighting significant improvements in progression-free survival, overall survival, and pathological complete response rates. Adverse reactions, immunogenicity, drug interactions, and use in specific populations are also covered. The FDA requested additional data, including literature reviews and pharmacovigilance reports, to support labeling changes.
Key findings — cited to the page
| Diarrhea (all grades) | 66.8 % | Study 1 · p.16 |
| Neutropenia (Grade 3-4) | 48.9 % | Study 1 · p.16 |
| Diarrhea (Grade 3-4) | 7.9 % | Study 1 · p.16 |
| Neutropenia (all grades) | 52.8 % | Study 1 · p.16 |
| Febrile neutropenia (all grades) | 13.8 % | Study 1 · p.16 |
| Febrile neutropenia (Grade 3-4) | 13.0 % | Study 1 · p.16 |
| Grade 3 – 4 hypersensitivity/anaphylaxis reactions incidence (placebo-treated group) | 2.5 % | placebo · p.14 |
| Grade 3 – 4 hypersensitivity/anaphylaxis frequency (PERJETA + TCH group) | 2.6 % | · p.14 |
| Grade 3 or 4 infusion reactions | Less than 1 % | · p.14 |
| Grade 3 – 4 hypersensitivity/anaphylaxis reactions incidence (PERJETA-treated group) | 2.0 % | PERJETA · p.14 |
| Median duration of study treatment (placebo-treated group) | 11.8 months | Study 1 · p.15 |
| Number of patients in Study 1 | 804 | Study 1 · p.15 |
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 →