Trabectedin Accord (trabectedin)
- Region
- 🇪🇺 EU
- Active substance
- trabectedin
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Sarcoma; Ovarian Neoplasms
- CHMP opinion
- Thu 27 Feb 2025
- EU approval
- Fri 25 Apr 2025
- Designations
- Generic, Additional monitoring
- Application
- EMEA/H/C/006433
- ATC
- L01CX01
- Official record
- www.ema.europa.eu
Indication
Trabectedin Accord is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Trabectedin Accord in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Yondelis Authorised · Pharma Mar S.A.
- 🇺🇸 Trabectedin Approved · Ever
- 🇪🇺 Yondelis Refused · Pharma Mar S.A.
- 🇺🇸 Evdi Approved · Apotex
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.