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) details its 2002 approval for breast cancer and non-small cell lung cancer (NSCLC). Efficacy was demonstrated in previously treated breast cancer and NSCLC patients, with a 75 mg/m2 dose proving tolerable and effective in NSCLC, unlike the 100 mg/m2 dose which showed unacceptable toxicity. The report comprehensively covers safety profiles across various doses and patient populations, including adverse events. A 2002 supplemental application (S-017) further updated the ADVERSE REACTIONS section with new post-marketing events like anorexia, bleeding, conjunctivitis, and lacrimal duct obstruction, alongside minor manufacturing and address changes.

Key findings — cited to the page

Neutropenia Grade 4 (<500 cells/mm3) at 60 mg/m2	74.9 %	TAXOTERE (docetaxel) · p.21
Infection Grade 3 and 4 with Elevated LFTs	33.3 %	TAXOTERE (docetaxel) · p.21
Infection Grade 3 and 4	7.1 %	TAXOTERE (docetaxel) · p.21
Infection Grade 3 and 4 at 60 mg/m2	0 %	TAXOTERE (docetaxel) · p.21
Thrombocytopenia Grade 4 (<20,000 cells/mm3)	0.6 %	TAXOTERE (docetaxel) · p.21
Thrombocytopenia Grade 4 (<20,000 cells/mm3) with Elevated LFTs	16.7 %	TAXOTERE (docetaxel) · p.21
Neutropenia Grade 4 (<500 cells/mm3) with Elevated LFTs	93.8 %	TAXOTERE (docetaxel) · p.21
Thrombocytopenia Grade 4 (<20,000 cells/mm3) at 60 mg/m2	1.1 %	TAXOTERE (docetaxel) · p.21
Neutropenia Grade 4 (<500 cells/mm3)	84.4 %	TAXOTERE (docetaxel) · p.21
grade 3/4 diarrhea (75 mg/m2, NSCLC)	2.8 %	· p.33
grade 3/4 nausea (75 mg/m2, NSCLC)	5.1 %	· p.33
grade 3/4 skin (75 mg/m2, NSCLC)	0.6 %	· p.33

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 →