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 | Under Review |
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 (target date) | June 3, 2016 |
Feedback Deadline (target date) ‡ | |
pERC Reconsideration Meeting (target date) | |
Final Recommendation Issued (target date) | |
Notification to Implement Issued |