Treanda-Rituximab for Chronic Lymphocytic Leukemia - Details


( Last Updated : September 26, 2014)
Generic Name:
Bendamustine hydrochloride
Project Status:
Withdrawn
Therapeutic Area:
Chronic Lymphocytic Leukemia
Manufacturer:
Lundbeck Canada Inc.
Brand Name:
Treanda (in combination with rituximab)
Project Line:
Reimbursement Review
Project Number:
PC0040-000

Details

Strength:
25mg/vial and 100mg/vial
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia
Funding Request:
For the first-line treatment of patients with chronic lymphocytic leukemia in combination with rituximab
Review Status:
Withdrawn
Pre Noc Submission:
Yes
Sponsor:
Lundbeck Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Clarification:
Lundbeck Canada Inc. has requested a voluntary withdrawal of the Bendamustine (Treanda) in combination with rituximab for CLL Submission in anticipation of new clinical information and possible resubmission. As per pCODR Procedures B3.1.6.2 b), the pCODR Secretariat has stopped the review. The pCODR Provincial Advisory Group has agreed with the manufacturer's request.

‡ 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.