SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2016)
Sanofi · 2016 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the December 2015 sNDA for Taxotere (docetaxel), primarily adding permanent alopecia to its labeling based on postmarketing reports. The document comprehensively covers Taxotere's indications across various cancers (breast, lung, prostate, gastric, head and neck), dosage, administration, stability, and forms. It outlines contraindications, warnings (e.g., toxic deaths, hepatic impairment, hypersensitivity, fluid retention), and adverse reactions observed in clinical trials, comparing monotherapy and combination regimens. Efficacy data from randomized trials demonstrate survival benefits and response rates. The report also addresses pharmacokinetic properties and use in specific populations.
Key findings — cited to the page
| percentage of cases with alopecia described as permanent/irreversible/>2 years | 5.3 % | Docetaxel · p.72 |
| number of cases with alopecia described as permanent/irreversible/>2 years | 117 | Docetaxel · p.72 |
| Desquamation (Grade 3/4) | 0 % | · p.39 |
| Dry skin (Grade 3/4) | 0 % | · p.39 |
| Diarrhea (Grade 3/4) | 2 % | · p.37 |
| Cough (Grade 3/4) | 0 % | · p.37 |
| Alopecia (Grade 3/4) | 4 % | · p.39 |
| Neuromotor (Grade 3/4) | 1 % | · p.39 |
| Alopecia (Grade 3/4) | 1 % | · p.39 |
| Rash/itch (Grade 3/4) | 0 % | · p.39 |
| Rash/itch (Grade 3/4) | 1 % | · p.39 |
| Nausea (Grade 3/4) | 3 % | · p.37 |
Source: Sanofi ↗ · 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 →