Yondelis (trabectedin)
- Region
- 🇪🇺 EU
- Active substance
- trabectedin
- Company
- Pharma Mar S.A.
- Status
- Authorised
- Therapeutic area
- Ovarian Neoplasms; Sarcoma
- EU approval
- Mon 17 Sep 2007
- Application
- EMEA/H/C/000773
- ATC
- L01CX01
- Official record
- www.ema.europa.eu
Indication
Yondelis is indicated for the treatment of 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. Yondelis 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
- 🇺🇸 Trabectedin Approved · Ever
- 🇪🇺 Trabectedin Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 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.