Trabectedin
A chemotherapy derived from a sea squirt, used with liposomal doxorubicin in relapsed ovarian cancer in Europe and for sarcomas.
OVA-301 showed a PFS benefit with pegylated liposomal doxorubicin in partially platinum-sensitive relapse; approved in the EU (2009) for ovarian cancer but not in the US for this indication. INOVATYON found no OS advantage over platinum. US approval covers liposarcoma and leiomyosarcoma (2015).
- Route
- Intravenous (central line)
- Schedule
- 1.1 mg/m² with PLD every 3 weeks (ovarian, EU); 1.5 mg/m² 24-hour infusion every 3 weeks (sarcoma)
- Monitoring
- Liver function, CPK, CBC; dexamethasone premedication
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- Johnson & Johnson withMe
- Johnson & Johnson Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Advanced soft tissue sarcoma after anthracyclines and ifosfamide
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA185 · SMC advice: trabectedin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| EU | 2009 | Relapsed platinum-sensitive ovarian cancer with PLD |
| US | 2015 | Liposarcoma and leiomyosarcoma after anthracycline |
| US | 2015 | Unresectable/metastatic liposarcoma or leiomyosarcoma after anthracycline |
| EU | 2007 | Advanced soft-tissue sarcoma after anthracycline/ifosfamide |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia grade 3-4 OVA-301 combination arm | — | 63% |
| ALT increase grade 3-4 | — | 31% |
| ALT elevation ET743-SAR-3007 | — | 26% |
| Neutropenia | — | 37% |
| Rhabdomyolysis | 0.7% | — |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Trabectedin" OR ABSTRACT:"Trabectedin" OR TITLE:"Yondelis" OR ABSTRACT:"Yondelis") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trabectedin, not a curated reading list.