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Votrient for Soft Tissue Sarcoma

Project Number pCODR 10009
Brand Name Votrient
Generic Name Pazopanib Hydrochloride
Strength 200 mg
Tumour Type Sarcoma
Indication Soft Tissue Sarcoma (STS)
Funding Request Adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Funding is not requested for patients with GIST and adipocytic soft tissue sarcomas.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 12, 2012
Manufacturer GlaxoSmithKline Inc.
Submitter GlaxoSmithKline Inc.
Submission Date June 4, 2012
Submission Deemed Complete June 11, 2012
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ June 18, 2012
Check-point meeting July 24, 2012
pERC Meeting September 20, 2012
Initial Recommendation Issued October 4, 2012
Feedback Deadline ‡ October 19, 2012
pERC Reconsideration Meeting November 15, 2012
Final Recommendation Issued November 29, 2012
Notification to Implement Issued December 14, 2012

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.