| 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 |
PLOCABULIN ( PM184 ) Y ECUBECTEDIN ( PM14 ) QUE DEBIAN INTENTAR SER EL RELEVO AL LURBINECTEDIN ... HAN PASADO A MEJOR VIDA . AHORA LOS SIGUIENTES EN EL INTENTO SON PM54 Y PM 534 QUE AUN ESTÁN RECLUTANDO PACIENTES EN LA FASE I .