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Zydelig for Chronic Lymphocytic Leukemia – Details

Project Number pCODR 10057
Brand Name Zydelig
Generic Name Idelalisib
Strength 100mg and 150mg tablets
Tumour Type Leukemia
Indication Chronic Lymphocytic Leukemia
Funding Request In combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL)
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date March 27, 2015
Manufacturer Gilead Sciences, Inc.
Submitter Gilead Sciences, Inc.
Submission Date April 7, 2015
Submission Deemed Complete April 14, 2015
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 21, 2015
Check-point meeting May 28, 2015
pERC Meeting July 16, 2015
Initial Recommendation Issued July 30, 2015
Feedback Deadline ‡ August 14, 2015
Final Recommendation Issued August 18, 2015
Notification to Implement Issued September 2, 2015

‡ 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.