SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2024)
Sanofi · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package for Sanofi-Aventis's Taxotere (docetaxel) details its approval, indications for various cancers (breast, lung, prostate, gastric, head and neck), and dosage guidelines. It outlines dose modifications for combination therapies and toxicities like diarrhea, thrombocytopenia, and liver dysfunction. The report provides extensive safety data, including hematologic toxicities, infections, hypersensitivity, and neurosensory issues, from clinical trials and postmarketing experience. Efficacy data are presented for Taxotere monotherapy and combination regimens across multiple cancer types, demonstrating improved survival and time to progression in some cases. Recent labeling updates include warnings for tumor lysis syndrome and myositis, prompted by postmarketing surveillance.
Key findings — cited to the page
| TAXOTERE dose reduction for second episode of Stomatitis/mucositis grade 4 | 20% | · p.15 |
| Grade 4 neutropenia (<500 cells/mm3) incidence with TAXOTERE (60 mg/m2) | 75% | · p.19 |
| TAXOTERE dose reduction for second episode of Diarrhea grade 3 | 20% | · p.15 |
| TAXOTERE dose reduction for third episode of Stomatitis/mucositis grade 3 | 20% | · p.15 |
| Fluorouracil dosage reduction for grade 2 or greater plantar-palmar toxicity | 20% | · p.16 |
| Grade 4 neutropenia (<500 cells/mm3) incidence with TAXOTERE (100 mg/m2) | 85% | · p.19 |
| TAXOTERE dose reduction for grade 4 thrombocytopenia | 75 mg/m2 to 60 mg/m2 | · p.15 |
| Fluorouracil dose reduction for first episode of Diarrhea grade 3 | 20% | · p.15 |
| TAXOTERE and fluorouracil dose reduction for first episode of Diarrhea grade 4 | 20% | · p.15 |
| Fluorouracil dose reduction for first episode of Stomatitis/mucositis grade 3 | 20% | · p.15 |
| Cisplatin dose reduction for Grade 2 peripheral neuropathy | 20% | · p.16 |
| Gastrointestinal bleeding (any grade) | 4 % | TAX323 · p.41 |
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 →