Janssen Products, a Johnson & Johnson company, has informed PharmaMar, a Zeltia company, that regulatory authorities in ten countries have granted 14 new authorisations to sell Yondelis (trabectedin): ten for treating relapsed platinum-sensitive ovarian cancer (ROC) in combination with Caelyx (pegylated liposomal doxorubicin), and four as monotherapy for treating soft tissue sarcoma (STS). Yondelis is administered via slow infusion.
As a result, Yondelis is now approved in 73 countries, 30 of which are in the EEA. The EC approved the sale of Yondelis in combination with pegylated liposomal doxorubicin for ROC at the end of 2009. Since then, the drug has been approved and commenced sale in other territories. The EC approved Yondelis for STS in 2007. Yondelis has orphan drug status for STS and OC in the EU, the US and Switzerland, and for STS in Japan and South Korea.
According to the licensing agreement between PharmaMar and Janssen Products, PharmaMar has the rights to sell Yondelis in Europe (including Eastern Europe), while Janssen Products has the rights to sell the drug everywhere else except Japan, where PharmaMar has granted a licence to Taiho Pharmaceutica (Otsuka) for the product's development and sale.
Yondelis is Spain's first antitumour drug. It is currently approved for STS in 42 countries outside the EEA, and for platinum-sensitive ROC in 31 of those countries plus Brazil. Yondelis is also undergoing Phase II trials on breast and paediatric cancers.