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Folotyn for Peripheral T-Cell Lymphoma

Project Number pCODR 10138
Brand Name Folotyn
Generic Name Pralatrexate
Strength 20 mg/1 mL & 40 mg/2 mL
Tumour Type Lymphoma
Indication Peripheral T-Cell Lymphoma (PTCL)
Funding Request for the treatment of patients with relapsed or refractory PTCL
Review Status Under Review
Pre Noc Submission Yes
NOC Date October 26, 2018
Manufacturer Servier Canada Inc.
Submitter Servier Canada Inc.
Submission Date June 1, 2018
Submission Deemed Complete June 8, 2018
Submission Type New Drug
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ June 15, 2018
Check-point meeting August 7, 2018
pERC Meeting January 17, 2019
Initial Recommendation Issued January 31, 2019
Feedback Deadline ‡ February 14, 2019
pERC Reconsideration Meeting March 21, 2019
Final Recommendation Issued (target date) April 4, 2019
Notification to Implement Issued
Clarification The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided.

‡ 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.