Tafinlar for Metastatic Melanoma - Details


( Last Updated : December 20, 2013)
Generic Name:
Dabrafenib
Project Status:
Complete
Therapeutic Area:
Metastatic Melanoma
Manufacturer:
GlaxoSmithKline
Brand Name:
Tafinlar
Project Line:
Reimbursement Review
Project Number:
PC0025-000
NOC Date:

Details


Strength:
50 mg and 75 mg capsule
Tumour Type:
Skin and Melanoma
Indications:
Metastatic Melanoma
Funding Request:
For use as monotherapy for the treatment of patients with unresectable or metastatic melanoma, with a BRAF V600 mutation
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
GlaxoSmithKline
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:
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
Funding Request:
For use as monotherapy for the treatment of patients with unresectable or metastatic melanoma, with a BRAF V600 mutation
pERC Meeting:
Final Recommendation Issued:

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.