SANOFI AVENTIS US — Taxotere FDA Review (NDA/BLA 020449, 2020)
Sanofi · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package for Taxotere (docetaxel), approved December 13, 2013, details its efficacy and safety across multiple cancer indications, including breast, non-small cell lung, prostate, gastric, and head and neck cancers. Clinical trials demonstrate improved survival and response rates, both as monotherapy and in combination regimens. The document outlines dosage adjustments for adverse events like neutropenia and fluid retention, and specific administration guidelines. Safety data highlights common toxicities such as hematologic effects, hypersensitivity, and fluid retention. Updates to prescribing information include new warnings for eye disorders (cystoid macular edema) and hyponatremia, identified as post-marketing experiences. The report also addresses use in specific populations and embryotoxic effects.
Key findings — cited to the page
| grade 4 thrombocytopenia <20,000 cells/mm3 (TAXOTERE 100 mg/m2, Normal LFTs) | 1 % | · p.28 |
| grade 3 and 4 infection (TAXOTERE 100 mg/m2, Normal LFTs) | 7 % | · p.28 |
| grade 4 neutropenia (TAXOTERE 60 mg/m2) | 75 % | · p.20 |
| grade 4 neutropenia <500 cells/mm3 (TAXOTERE 60 mg/m2, Normal LFTs) | 75 % | · p.28 |
| grade 4 thrombocytopenia <20,000 cells/mm3 (TAXOTERE 100 mg/m2, Elevated LFTs) | 17 % | · p.28 |
| grade 4 thrombocytopenia <20,000 cells/mm3 (TAXOTERE 60 mg/m2, Normal LFTs) | 1 % | · p.28 |
| dry skin (any grade) | 6 % | TAX323 · p.40 |
| dose reduction for severe neutropenia, febrile neutropenia, or grade 4 infection | 25 % | · p.20 |
| grade 4 neutropenia <500 cells/mm3 (TAXOTERE 100 mg/m2, Normal LFTs) | 84 % | · p.28 |
| grade 4 neutropenia <500 cells/mm3 (TAXOTERE 100 mg/m2, Elevated LFTs) | 94 % | · p.28 |
| grade 4 neutropenia (TAXOTERE 100 mg/m2) | 85 % | · p.20 |
| grade 3 and 4 infection (TAXOTERE 100 mg/m2, Elevated LFTs) | 33 % | · p.28 |
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 →