Prescription medicine
Trabectedin Brand names: Evdi, Yondelis
Trabectedin (Yondelis) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the trabectedin FDA label on DailyMed (effective June 29, 2026, Apotex Corp.); the NDA 207953 record on Drugs@FDA; every trabectedin label on DailyMed.
Highlights of the record
FDA label of June 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEVDI is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14) ].
Forms and strengths
- 0.05 mg/ml
Injection (solution) (concentrate); injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- October 23, 2015 Yondelis, Janssen Prods; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 7, 2028 Yondelis injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,310 through July 30, 2026
What is trabectedin used for?
From the label: indications and usageEVDI is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen [see Clinical Studies (14) ]. EVDI is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (EVDI), Apotex Corp., effective June 29, 2026 (SPL set c1d50f5c-4202-27f3-4798-a9708114ddea), via openFDA; the full label on DailyMed
Is there a generic for trabectedin (Yondelis)?
No generic trabectedin is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 1 patent for Yondelis injection, the last expiring on July 7, 2028; a patent listed only for Evdi injection runs to February 18, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the trabectedin label say about other medicines?
The trabectedin label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name trabectedin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
| Dacarbazine | warnings and precautions | Elevations in creatine phosphokinase (CPK) occurred in 122 (32%) of the 378 patients receiving trabectedin, including Grade 3 or 4 CPK elevation in 24 patients (6%), compared to 15 (9%) of the 172 patients receiving dacarbazine with any CPK elevation, including 1 patient (0.6%) with Grade 3 CPK elevation. |
| Itraconazole | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
| Ketoconazole | drug interactions | Mechanism and Clinical Effect (s); Concomitant administration of trabectedin with ketoconazole, a strong CYP3A inhibitor, increased systemic exposure of trabectedin by 66% [see Clinical Pharmacology ()]. |
| Nefazodone | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
| Nelfinavir | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
| Phenobarbital | drug interactions | Avoid using strong CYP3A inducers (e.g., rifampin, phenobarbital, St. John's wort) in patients taking YONDELIS [see Clinical Pharmacology (12.3) ]. |
| Posaconazole | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
| Rifampin | drug interactions | Mechanism and Clinical Effect (s); Concomitant administration of trabectedin with rifampin, a strong CYP3A4 inducer, decreased systemic exposure of trabectedin by 31% [see Clinical Pharmacology ()]. |
| Ritonavir | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
| Voriconazole | drug interactions | Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. |
Source: FDA drug label (EVDI), Apotex Corp., effective June 29, 2026 (SPL set c1d50f5c-4202-27f3-4798-a9708114ddea), via openFDA; the full label on DailyMed
What do FAERS reports show for trabectedin?
The FDA Adverse Event Reporting System holds 2,310 reports that list trabectedin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 445 are coded as a death and 1,035 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Trabectedin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other