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 new indications in HER2-positive early breast cancer, including neoadjuvant and adjuvant treatments. This approval, supported by trials like APHINITY and BERENICE, demonstrated significant improvements in invasive disease-free survival (IDFS) and pathological complete response (pCR) rates, particularly for high-risk patients. The report details Perjeta's efficacy and safety profile in combination with other therapies, highlighting adverse reactions such as left ventricular dysfunction, infusion-related reactions, and diarrhea. Cardiac safety was a key focus, with postmarketing requirements fulfilled and an acceptable cardiac safety profile confirmed despite a slightly higher incidence of certain adverse events in the pertuzumab arm. The document also covers regulatory history, clinical pharmacology, immunogenicity, and specific population considerations.
Key findings — cited to the page
| SAEs of any grade in BERENICE Cohort A | 45 | BERENICE · p.144 |
| incidence of grade 3-4 adverse events (diarrhea, comparator) | 4% | APHINITY trial · p.65 |
| SAEs of any grade in BERENICE Cohort B | 52 | BERENICE · p.144 |
| incidence of grade 3-4 adverse events (diarrhea) | 10% | APHINITY study · p.63 |
| incidence of grade 3-4 adverse events (diarrhea, comparator) | 4% | APHINITY study · p.63 |
| incidence of grade 3-4 adverse events (diarrhea) | 10% | APHINITY trial · p.65 |
| Grade 3 diarrhea | 40% | · p.68 |
| Grade 3-4 febrile neutropenia (patients >= 75 years) | 13 % | · p.33 |
| Grade 3-4 diarrhea (patients >= 75 years) | 17 % | · p.33 |
| Grade 3-4 diarrhea (patients >= 65 years) | 15 % | · p.33 |
| Grade 3-4 neutropenia (patients >= 75 years) | 23 % | · p.33 |
| Grade 3-4 neutropenia (patients >= 65 years) | 22 % | · 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 →