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Caprelsa for Medullary Thyroid Cancer – Details

Project Number pCODR 10090
Brand Name Caprelsa
Generic Name Vandetanib
Strength 100 mg and 300 mg tablets
Tumour Type Endocrine
Indication Medullary Thyroid Cancer
Funding Request For the treatment of symptomatic and/or progressive medullary thyroid cancer in adult patients with unresectable locally advanced or metastatic disease
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date January 12, 2012
Manufacturer Sanofi Genzyme
Sponsor Sanofi Genzyme
Submission Date August 15, 2016
Submission Deemed Complete August 22, 2016
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ August 29, 2016
Check-point meeting October 17, 2016
pERC Meeting January 19, 2017
Initial Recommendation Issued February 2, 2017
Feedback Deadline ‡ February 16, 2017
pERC Reconsideration Meeting March 16, 2017
Final Recommendation Issued March 30, 2017
Notification to Implement Issued April 17, 2017

‡ 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.