Following the setback suffered at the hands of US regulators last week, Zeltia has been boosted by the news that its anticancer agent Yondelis has received approvals in five new countries.
The Spanish drugmaker’s PharmaMar unit has been told by its US partner Johnson & Johnson that Yondelis (trabectedin) has been approved by regulators in Mexico, Chile, Uruguay, Singapore and Vietnam for the treatment of advanced soft tissue sarcoma (STS) in adults. This means that the drug has now been approved for STS in 12 countries outside the European Economic Area.
The others are Argentina, Colombia, South Korea, Macau, the Philippines, Russia and Switzerland, and PharmaMar has already started to receive royalties from sales in these countries. Yondelis was approved in the European Union for STS in September 2007.
The news is very welcome for Zeltia especially as last week the US Food and Drug Administration had issued a complete response letter regarding the New Drug Application for Yondelis when administered in combination with J&J’s Doxil (doxorubicin). The latter’s Centocor Ortho Biotech unit said that the agency has requested additional information, “including overall survival data from the company’s ongoing pivotal trial and additional clinical pharmacology studies”.
The ovarian cancer indication would be a lucrative one and both Zeltia and J&J have expressed confidence in the product. Yondelis has already been approved for ovarian cancer in the Philippines and a decision on the approval for this indication from European regulators is expected by the end of the year.
