IMCLONE — Erbitux FDA Review (NDA/BLA 125084, 2021)
Eli Lilly and Company · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Erbitux (cetuximab) on April 6, 2021, for head and neck cancer and K-Ras wild-type, EGFR-expressing metastatic colorectal cancer (mCRC). This approval included a new biweekly (Q2W) dosing option (500 mg/m2 Q2W) in addition to the existing weekly (Q1W) regimen, based on a supplemental Biologics License Application. Clinical trials (BONNER, EXTREME, CRYSTAL, APEC, CA225-025, CP02-9923, BOND) and real-world data demonstrated comparable efficacy (locoregional control, overall survival, progression-free survival, objective response rates) and safety profiles between Q1W and Q2W regimens across indications. While Q2W showed a slightly lower Cmin, overall pharmacokinetics and adverse event rates (including infusion reactions, cardiopulmonary arrest, dermatologic toxicities) were similar. The review concluded that the Q2W regimen is safe and effective for all approved indications.
Key findings — cited to the page
| Grade 3-4 Paronychia (Q2W pooled) | 11 % | · p.39 |
| Grade 3-4 Paronychia (APEC-FOLFIRI (Q2W)) | 10 % | APEC · p.39 |
| Hypomagnesemia (any grade) | 55 % | Study CA225-025 and two other clinical trials · p.15 |
| Hypomagnesemia (any grade) with cetuximab, carboplatin, and fluorouracil | 4 % | · p.15 |
| Hypomagnesemia (Grade 3 or 4) with cetuximab + cisplatin and fluorouracil | 7 % | EXTREME · p.15 |
| Hypomagnesemia (any grade) with cetuximab + cisplatin and fluorouracil | 14 % | EXTREME · p.15 |
| Severe (Grades 3 and 4) infusion reactions | 2.2 % | · p.13 |
| Infusion reactions (any grade) | 8.4 % | · p.13 |
| Severe (Grades 3 or 4) acneiform rash | 9.7 % | · p.14 |
| Acneiform rash (any grade) | 82 % | · p.14 |
| Hypomagnesemia (Grades 3 and 4) | 6 to 17 % | Study CA225-025 and two other clinical trials · p.15 |
| Grade 3-4 Paronychia (CRYSTAL (Q1W)) | 4 % | CRYSTAL · p.39 |
Source: Eli Lilly and Company ↗ · 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 →