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|
|Tumour Type||Skin and 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|
|Sponsor||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.