Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed soft tissue sarcoma 1 milestone | |||||
| Filed | US (FDA) | YONDELIS | soft tissue sarcoma | 2014-11-24 | “Janssen Research & Development, LLC (Janssen) has submitted a New Drug Application (NDA) for YONDELIS® (trabectedin) to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | YONDELIS | — | 2018-06-29 | fda.gov ↗ |
| Approved | US (FDA) | YONDELIS | — | 2015-10-23 | fda.gov ↗ |
| Approved | EU (EMA) | Yondelis | — | 2007-09-17 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Yondelis | — | 2004-09-07 | europa.eu ↗ |
Trials 78 · started per year
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-04-28 | PharmaMar | Results PharmaMar presents eleven scientific publications at the Annual Meeting of the American Association for Cancer Research (AACR) pharmamar.com ↗
On this occasion, the Company is presenting eleven new studies with results on the activity of its compounds: lurbinectedin (Zepzelca®), ecubectedin, PM54, PM534, and trabectedin (Yondelis®). |
| 2023-05-26 | PharmaMar | Results PharmaMar announces abstracts to be presented at ASCO 2023 pharmamar.com ↗
The study confirms the activity of trabectedin plus nivolumab, particularly in patients with lipo- or leiomyosarcomas, suggesting synergistic activity. |
| 2022-09-08 | PharmaMar | Results PharmaMar announces the data to be presented at ESMO 2022 pharmamar.com ↗
Trabectedin induces apoptosis regardless of acquired resistance to PARP inhibitors in BRCA2 mutant high grade ovarian cancer cell lines |
| 2022-08-17 | NATCO Pharma Ltd. | Regulatory NATCO announces tentative approval to its ANDA for Trabectedin (generic for Yondelis®) natcopharma.co.in ↗
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces today that the U.S. Food and Drug Administration has granted tentative approval to its Abbreviated New Drug Application (ANDA) for Trabectedin for Injection (generic for Yondelis® ) for the 1mg/vial presentation. |
| 2022-05-20 | Immix Biopharma, Inc. | Results ImmixBio IMX-110 Demonstrated Improved Survival Over U.S. Food and Drug Administration Approved Drug Trabectedin (sold as YONDELIS ® by Janssen, a Johnson & Johnson Company) in Connective Tissue Cancer Soft Tissue Sarcoma Mice Study immixbio.com ↗
One cycle of IMX-110 produced 75% survival vs. 0% survival for Trabectedin |
| 2021-09-20 | PharmaMar | Results New results with Yondelis® (trabectedin) in sarcoma will be presented at ESMO 2021 pharmamar.com ↗
In the combination arm of trabectedin with doxorubicin, median PFS reached 12.2 months, compared to 6.2 months with single-agent doxorubicin (HR = 0.41; 95% CI 0.29-0.58; P<0.0001). |
| 2021-04-23 | PharmaMar | Regulatory The Australian TGA approves Yondelis® (trabectedin) for Soft Tissue Sarcoma (Liposarcoma or Leiomyosarcoma) pharmamar.com ↗ |
| 2015-10-23 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves YONDELIS® (trabectedin) for the Treatment of Patients with Unresectable or Metastatic Liposarcoma or Leiomyosarcoma, Two Common Subtypes of Soft Tissue Sarcoma jnj.com ↗
Janssen Biotech, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved YONDELIS® (trabectedin) for the treatment of patients with unresectable (unable to be removed with surgery) or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who received a prior anthracycline-containing regimen. |
| 2015-02-03 | Janssen Research & Development, LLC | Regulatory U.S. FDA Grants Priority Review for YONDELIS® (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma jnj.com ↗
U.S. FDA Grants Priority Review for YONDELIS® (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma |
| 2014-11-24 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application for YONDELIS® (trabectedin) to U.S. FDA for the Treatment of Patients with Advanced Soft Tissue Sarcoma jnj.com ↗
Janssen Submits New Drug Application for YONDELIS® (trabectedin) to U.S. FDA for the Treatment of Patients with Advanced Soft Tissue Sarcoma |
All press releases naming this drug 13 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 93 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trabectedin | “Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300 mcg/m2 once every 21 days (Treatment B) will be given to patients” NCT00050427 ↗83“Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer.” NCT00060944 ↗ “Doxorubicin and ifosfamide or doxorubicin monotherapy or doxorubicin and trabectedin.” NCT06333314 ↗ “Trabectedin Presentation: vials with trabectedin 1 mg and sucrose 400 mg.” NCT01104298 ↗ “Study drugs include trabectedin and rifampin.” NCT01273480 ↗ |
| Known as | Ecteinascidin | “A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules” NCT00060944 ↗ |
| Known as | ecteinascidin 743 | “While investigating the novel anticancer drug ecteinascidin 743 (Et743), a natural marine product isolated from the Caribbean sea squirt, we discovered a new cell-killing...” PMID 11479630 ↗ Aug 2001 |
| Known as | ET-743 | “The cytotoxic activity of ecteinascidin 743 (ET-743), a natural product derived from the marine tunicate Ecteinascidia turbinata that exhibits potent anti-tumor activity in...” PMID 11304695 ↗ May 20016“While investigating the novel anticancer drug ecteinascidin 743 (Et743), a natural marine product isolated from the Caribbean sea squirt, we discovered a new cell-killing...” PMID 11479630 ↗ Aug 2001 “A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules” NCT00060944 ↗ “A phase II study of ET-743/trabectedin ('Yondelis') for patients with advanced gastrointestinal stromal tumours.” PMID 15177491 ↗ Jun 2004 “ET-743, Yondelis (vials of 1 mg). Route of administration: intravenous infusion” NCT05131386 ↗ “Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])” NCT01453283 ↗ |
| Known as | Yondelis | “PURPOSE: To determine the dose-limiting toxicity (DLT) and the maximum tolerated dose of ecteinascidin-743 (ET-743, Yondelis) in children with refractory solid tumors, to...” PMID 15701855 ↗ Jan 20059“A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or...” NCT01846611 ↗ “A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)” NCT00796120 ↗ “A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma” NCT00579501 ↗ “A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma” NCT01343277 ↗ “A phase II study of ET-743/trabectedin ('Yondelis') for patients with advanced gastrointestinal stromal tumours.” PMID 15177491 ↗ Jun 2004 “The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin” NCT00102609 ↗ “combination of trabectedin (Yondelis®)” NCT04887961 ↗ “Trabectedin 1 MG [Yondelis]” NCT04067115 ↗ |
| Known as | YONDELIS [R] | “Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])” NCT01453283 ↗ |
| Action | Inhibit | “ET-743 downregulated TLS:CHOP expression” PMID 22293175 ↗ Feb 2012 |
| Modality | Small molecule | “Trabectedin (ET-743) is a marine alkaloid isolated from the Caribbean tunicate Ecteinascidia turbinata, with a chemical structure characterized by three fused...” PMID 20647340 ↗ Jul 2010 |
| Route | Intravenous | “administered as a single intravenous infusion” NCT00002904 ↗ |
| Target | FLI1 | “Trabectedin above a threshold concentration reverses the activity of EWS::FLI1 and is potentiated by low-dose irinotecan in vivo.” PMID 41991689 ↗ Apr 2026 |