Last Updated : October 24, 2018
Details
Generic Name:
Belinostat
Project Status:
Withdrawn
Manufacturer:
Servier Canada Inc.
Brand Name:
Beleodaq
Project Line:
Reimbursement Review
Project Number:
PC0139-000
Tumour Type:
Lymphoma
Indications:
Peripheral T-Cell Lymphoma (PTCL)
Funding Request:
For the treatment of patients with relapsed or refractory PTCL
Review Status:
Withdrawn
Pre Noc Submission:
Yes
Sponsor:
Servier Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Clarification:
Servier Canada Inc. has notified pCODR that the Category 2 submission requirements for the pre NOC submission of Belinostat (Beleodaq) for Peripheral T-Cell Lymphoma (PTCL) cannot be met at this time. As per pCODR Procedures C3.1.6, the pCODR program has stopped the review.
‡ 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.
Last Updated : October 24, 2018