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Vismodegib (Erivedge) for Advanced BCC - Details

Brand Name Erivedge
Generic Name Vismodegib
Strength 150 mg capsule
Tumour Type Skin and Melanoma
Indication Advanced Basal Cell Carcinoma
Funding Request For the treatment of adult patients with histologically confirmed metastatic basal cell carcinoma or with locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 12, 2013
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date June 14, 2013
Submission Deemed Complete June 21, 2013
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ June 28, 2013
Check-point meeting August 28, 2013
pERC Meeting October 17, 2013
Initial Recommendation Issued October 31, 2013
Feedback Deadline ‡ November 15, 2013
pERC Reconsideration Meeting December 19, 2013
Final Recommendation Issued January 10, 2014
Notification to Implement Issued January 27, 2014

‡ 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.