03 junio 2016

Yondelis for Liposarcoma or Leiomyoscarcoma ( CANADA ) . CADTH Pancanadiense Oncología Drug Review .

Brand NameYondelis
Generic NameTrabectedin
Strength1mg/vial
Tumour TypeSarcoma
IndicationMetastatic Liposarcoma or Leiomyosarcoma
Funding RequestFor the treatment of patients with metastatic liposarcoma or leiomyosarcoma after failure of prior anthracycline and ifosfamide chemotherapy
Review StatusUnder Review
Pre Noc SubmissionNo
NOC DateJuly 14, 2011
ManufacturerJanssen Inc.
SubmitterJanssen Inc.
Submission DateDecember 22, 2015
Submission Deemed CompleteJanuary 6, 2016
Submission TypeNew Indication
Prioritization RequestedNot Requested
Stakeholder Input Deadline ‡January 13, 2016
Check-point meetingMarch 2, 2016
pERC MeetingMay 19, 2016
Initial Recommendation Issued (target date)June 3, 2016
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued