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Votrient for metastatic renal cell carcinoma - Details

CLARIFICATION: The manufacturer, GlaxoSmithKline Inc. has resubmitted to pCODR for Pazopanib Hydrochloride (Votrient) submission. Please see the Pazopanib hydrochloride (Votrient) for Metastatic Renal Cell Carcinoma Resubmission Details page for more information.

Project Number pCODR 10000
Brand Name Votrient
Generic Name Pazopanib hydrochloride
Strength 200 mg
Tumour Type Genitourinary
Indication Metastatic Renal Cell Carcinoma
Funding Request First-line therapy in patients with metastatic renal cell (clear cell) carcinoma who have a Memorial Sloan Kettering Prognostic Score of Favourable or Intermediate Risk
Review Status Notification to Implement Issued (Resubmission Complete)
Pre Noc Submission No
NOC Date May 27, 2010
Manufacturer GlaxoSmithKline Inc.
Submitter GlaxoSmithKline Inc.
Submission Date July 14, 2011
Submission Deemed Complete July 21, 2011
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ July 28, 2011
Check-point meeting September 2, 2011
pERC Meeting October 20, 2011
Initial Recommendation Issued November 3, 2011
Feedback Deadline ‡ November 18, 2011
pERC Reconsideration Meeting December 15, 2011
Final Recommendation Issued January 5, 2012
Notification to Implement Issued January 20, 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.