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Treanda for Chronic Lymphocytic Leukemia (First Line)

As per pCODR Procedures B5.4, the pERC deliberations for Bendamustine (Treanda) First Line treatment of patients with CLL were deferred to the January 17, 2013 pERC meeting date, once the submitter provided the requested additional economic information. pERC issued a final recommendation for Bendamustine (Treanda) for Relapsed/Refractory CLL separately to the First Line indication. Please see the Bendamustine (Treanda) for Chronic Lymphocytic Leukemia (Relapsed/Refractory) Details page for more information.

Project Number pCODR 10011
Brand Name Treanda
Generic Name Bendamustine hydrochloride
Strength 25mg/vial and 100mg/vial
Tumour Type Leukemia
Indication Chronic lymphocytic leukemia (First Line)
Funding Request Patients with Chronic Lymphocytic Leukemia (first line) for whom fludarabine-based therapy is not appropriate
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date August 24, 2012
Manufacturer Lundbeck Canada Inc.
Submitter Lundbeck Canada Inc.
Submission Date April 24, 2012
Submission Deemed Complete May 1, 2012
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 8, 2012
Check-point meeting June 27, 2012
pERC Meeting January 17, 2013
Initial Recommendation Issued January 31, 2013
Feedback Deadline ‡ February 14, 2013
Final Recommendation Issued February 19, 2013
Notification to Implement Issued March 6, 2013
Clarification Time required for the submitter to provide additional information has impacted the review timeline.

‡ 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.