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Yondelis for Liposarcoma or Leiomyoscarcoma – Details

Project Number pCODR 10071
Brand Name Yondelis
Generic Name Trabectedin
Strength 1mg/vial
Tumour Type Sarcoma
Indication Metastatic Liposarcoma or Leiomyosarcoma
Funding Request For the treatment of patients with metastatic liposarcoma or leiomyosarcoma after failure of prior anthracycline and ifosfamide chemotherapy
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date July 14, 2011
Manufacturer Janssen Inc.
Submitter Janssen Inc.
Submission Date December 22, 2015
Submission Deemed Complete January 6, 2016
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ January 13, 2016
Check-point meeting March 2, 2016
pERC Meeting May 19, 2016
Initial Recommendation Issued June 3, 2016
Feedback Deadline ‡ June 17, 2016
pERC Reconsideration Meeting July 21, 2016
Final Recommendation Issued August 5, 2016
Notification to Implement Issued August 22, 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.