Zelboraf for Advanced Melanoma - Details


( Last Updated : August 1, 2012)
Generic Name:
Vemurafenib
Project Status:
Complete
Therapeutic Area:
Metastatic Melanoma
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Zelboraf
Project Line:
Reimbursement Review
Project Number:
PC0006-000
NOC Date:

Details


Strength:
240 mg
Tumour Type:
Skin and Melanoma
Indications:
Advanced Melanoma
Funding Request:
Treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Funding Request:
Treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma
pERC Meeting:
Final Recommendation Issued:

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.

Files

‡ 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.