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Zelboraf for Advanced Melanoma - Details

CLARIFICATION: Non-disclosable information was initially used in the pCODR Clinical Guidance Report and the manufacturer requested this information be redacted until September 29, 2012 pursuant to the pCODR Disclosure of Information Guidelines.

The information is now available in the public domain and the Clinical Guidance Report has been updated with information un-redacted.

Project Number pCODR 10006
Brand Name Zelboraf
Generic Name Vemurafenib
Strength 240 mg
Tumour Type Skin and Melanoma
Indication Advanced Melanoma
Funding Request Treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date February 15, 2012
Manufacturer Hoffmann-La Roche Limited
Submitter Hoffmann-La Roche Limited
Submission Date December 6, 2011
Submission Deemed Complete December 9, 2011
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ December 20, 2011
Check-point meeting January 30, 2012
pERC Meeting March 15, 2012
Initial Recommendation Issued March 29, 2012
Feedback Deadline ‡ April 16, 2012
pERC Reconsideration Meeting May 17, 2012
Final Recommendation Issued June 1, 2012
Notification to Implement Issued June 18, 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.