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Treanda-Rituximab for Chronic Lymphocytic Leukemia - Details

Project Number PC0040-000
Brand Name Treanda (in combination with rituximab)
Generic Name Bendamustine hydrochloride
Strength 25mg/vial and 100mg/vial
Tumour Type Leukemia
Indication 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Review Status Withdrawn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
NOC Date N/A
Manufacturer Lundbeck Canada Inc.
Sponsor Lundbeck Canada Inc.
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.
Submission Date June 27, 2014
Submission Deemed Complete July 30, 2014
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ July 14, 2014
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued
Therapeutic Area Chronic Lymphocytic Leukemia

‡ 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.