| 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. |
| Sponsor | 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.
