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sipuleucel-T (Provenge®)

Reference No. 274

Publication date:

Appraisal information

sipuleucel-T (Provenge®) 50 x 10⁶ CD54⁺ cells/250ml dispersion for infusion

Company: Dendreon UK Ltd
BNF category: Malignant disease and immunosupression
NMG meeting date: Not scheduled
AWMSG meeting date: Not scheduled
Submission Type: Nonsubmission
Status: Marketing authorisation withdrawn
Advice No: Not available
Ratification by Welsh Government: 26/02/2014

Current Progress

Ratification by
Welsh Government

AWMSG advice

LICENCE WITHDRAWN. Please refer to the European Medicines Agency website for further information. AWMSG ADVICE SUPERSEDED BY NICE GUIDANCE (TA332) NICE GUIDANCE ISSUED February 2015 (Refer to NICE website for full guidance on NICE recommendations, including any specific restrictions on the use of the technology) In the absence of a submission from the holder of the marketing authorisation, sipuleucel-T (Provenge®) cannot be endorsed for use within NHS Wales for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Statement of Advice (SOA)