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Istodax for Peripheral T-Cell Lymphoma - Details

Project Number pCODR 10048
Brand Name Istodax
Generic Name Romidepsin
Strength 10 mg per vial
Tumour Type Lymphoma
Indication Peripheral T-Cell Lymphoma
Funding Request For patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date October 16, 2013
Manufacturer Celgene Inc.
Sponsor Celgene Inc.
Submission Date December 1, 2014
Submission Deemed Complete December 18, 2014
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ December 15, 2014
Check-point meeting February 4, 2015
pERC Meeting April 16, 2015
Initial Recommendation Issued April 30, 2015
Feedback Deadline ‡ May 14, 2015
Final Recommendation Issued May 19, 2015
Notification to Implement Issued June 3, 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.