CHEPLAPHARM — Xeloda FDA Review (NDA/BLA 020896, 2023)
Cheplapharm · 2023 · FDA Review (Drugs@FDA)
Report summary
This FDA approval package for Xeloda (capecitabine) tablets, approved December 14, 2022, details its use for various cancers including colorectal, breast, gastric, esophageal, gastroesophageal junction, and pancreatic. The report covers dosage, administration, and critical safety information, including contraindications, warnings, and precautions related to cardiotoxicity, diarrhea, myelosuppression, and hyperbilirubinemia, with incidence rates from clinical trials. Efficacy data, often comparing Xeloda to other regimens, is presented for colorectal and metastatic breast cancer, highlighting outcomes like disease-free and overall survival. The document also outlines proposed labeling updates under Project Renewal, focusing on aligning with current regulations, clarifying adverse reaction definitions, and modifying dosage for renal impairment and hyperbilirubinemia. It also addresses regulatory requirements for 505(b)(2) supplements and pediatric assessments.
Key findings — cited to the page
| Stomatitis (all grades) | 22 % | X-ACT · p.22 |
| Abdominal pain (all grades) | 14 % | X-ACT · p.22 |
| Diarrhea (all grades) | 47 % | X-ACT · p.22 |
| Nausea (Grade 3 or 4) | 2 % | X-ACT · p.22 |
| Vomiting (all grades) | 15 % | X-ACT · p.22 |
| Vomiting (Grade 3 or 4) | 2 % | X-ACT · p.22 |
| Palmar-plantar erythrodysesthesia syndrome (all grades) | 60 % | X-ACT · p.22 |
| Palmar-plantar erythrodysesthesia syndrome (Grade 3 or 4) | 17 % | X-ACT · p.22 |
| Diarrhea (Grade 3 or 4) | 12 % | X-ACT · p.22 |
| Nausea (all grades) | 34 % | X-ACT · p.22 |
| Stomatitis (Grade 3 or 4) | 2 % | X-ACT · p.22 |
| Abdominal pain (Grade 3 or 4) | 3 % | X-ACT · p.22 |
Source: Cheplapharm ↗ · 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 →