SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2019)
Sanofi · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the October 5, 2018 approval of Taxotere (docetaxel) for various cancers including breast, non-small cell lung, castration-resistant prostate, gastric adenocarcinoma, and head and neck cancer. It outlines updates to the prescribing information, particularly concerning warnings and precautions for enterocolitis, neutropenic colitis, and hypersensitivity reactions, and provides detailed dosage and administration guidelines. The report comprehensively covers safety information, adverse reactions (hematologic, fluid retention, peripheral neuropathy, ototoxicity, nephrotoxicity), and dose modifications across diverse patient populations and treatment regimens (monotherapy and combination therapies). Efficacy data, including overall survival, progression-free survival, and response rates, are presented from numerous clinical trials for various cancer types. Regulatory reviews for supplemental NDAs, such as SLR-079, focused on updating adverse event information and persistent adverse events from long-term studies, leading to approved labeling changes.
Key findings — cited to the page
| grade 4 neutropenia (<500 cells/mm3) in breast cancer patients treated with TAXOTERE 100 mg/m2 with elevated LFTs | 94 % | · p.26 |
| grade 4 thrombocytopenia (<20,000 cells/mm3) in breast cancer patients treated with TAXOTERE 60 mg/m2 with normal LFTs | 1 % | · p.26 |
| dose reduction for severe neutropenia (<500 cells/mm3) lasting 7 days or more, febrile neutropenia, or grade 4 infection | 25 % | · p.18 |
| grade 4 neutropenia (<500 cells/mm3) in breast cancer patients treated with TAXOTERE 100 mg/m2 with normal LFTs | 84 % | · p.26 |
| grade 4 thrombocytopenia (<20,000 cells/mm3) in breast cancer patients treated with TAXOTERE 100 mg/m2 with normal LFTs | 1 % | · p.26 |
| grade 4 thrombocytopenia (<20,000 cells/mm3) in breast cancer patients treated with TAXOTERE 100 mg/m2 with elevated LFTs | 17 % | · p.26 |
| cisplatin dose reduction for Grade 2 peripheral neuropathy | 20 % | · p.15 |
| fluorouracil dosage reduction for grade 2 or greater plantar-palmar toxicity | 20 % | · p.15 |
| grade 4 neutropenia (<500 cells/mm3) in patients given 100 mg/m2 TAXOTERE | 85 % | · p.18 |
| grade 4 neutropenia (<500 cells/mm3) in patients given 60 mg/m2 TAXOTERE | 75 % | · p.18 |
| grade 4 neutropenia (<500 cells/mm3) in breast cancer patients treated with TAXOTERE 60 mg/m2 with normal LFTs | 75 % | · p.26 |
| grade 3 and 4 infection in breast cancer patients treated with TAXOTERE 100 mg/m2 with normal LFTs | 7 % | · p.26 |
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 →