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Zydelig for Follicular Lymphoma – Details

Project Number pCODR 10075
Brand Name Zydelig
Generic Name Idelalisib
Strength 100mg & 150mg Tablets
Tumour Type Lymphoma
Indication Follicular Lymphoma
Funding Request For the treatment of patients with follicular lymphoma who have received at least two prior systemic therapies and are refractory to both rituximab and an alkylating agent
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 12, 2016
Submission Deemed Complete April 19, 2016
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 26, 2016
Check-point meeting May 26, 2016
pERC Meeting July 21, 2016
Initial Recommendation Issued August 5, 2016
Feedback Deadline ‡ August 19, 2016
pERC Reconsideration Meeting September 15, 2016
Final Recommendation Issued September 29, 2016
Notification to Implement Issued October 17, 2016

‡ 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.