Sanofi — Taxotere EMA EPAR variation assessment report (EMEA/H/C/000073, 1995)

Sanofi · 1995 · EMA EPAR variation assessment report · company profile →

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This report assesses a Type II variation for Taxotere (docetaxel) to treat metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen-deprivation therapy (ADT). The application is primarily supported by the STAMPEDE trial, with CHAARTED and GETUG-AFU15 as supplemental studies. STAMPEDE and CHAARTED demonstrated significant overall survival (OS) and progression-free survival benefits for docetaxel + ADT compared to ADT alone. Although GETUG-AFU15 initially showed no significant OS benefit, long-term follow-up and secondary endpoints improved with docetaxel + ADT. The overall benefit-risk profile was considered positive, leading to a recommendation for marketing authorization extension. Safety concerns, mainly neutropenia and febrile neutropenia, were consistent with docetaxel's known profile.

Key findings — cited to the page

HR for OS	0.78	STAMPEDE · p.57
overall survival (HR)	0.77	meta-analysis · p.90
median overall survival (months)	47.2 months	CHAARTED · p.90
variation type	C.I.6.a	· p.92
variation type	Type II	· p.92
median OS (months)	43 months	STAMPEDE · p.27
median FFS (months)	20.4 months	STAMPEDE · p.27
median FFS (months)	12.0 months	STAMPEDE · p.27
HR for rPFS	0.69	GETUG-AFU15 · p.47
Type II variation application date	13 March 2019	· p.4
Extension of Indication	treatment of patients with metastatic hormone-sensitive prostate cancer in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone	Taxotere, Docetaxel Zentiva · p.4
CHMP Opinion date	19 September 2019	· p.5

Source: Sanofi ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →