FDA grants orphan drug status to STS treatment
The FDA has granted Orphan Drug status to Yondelis in the indication of Soft Tissue Sarcoma (STS).
The FDA has granted Orphan Drug status to Yondelis in the indication of Soft Tissue Sarcoma (STS).
The sponsor of this application in the US is Johnson & Johnson Pharmaceutical Research & Development. The European Commission already granted orphan drug status for this indication to Yondelis in 2001 in Europe, where PharmaMar is the applicant.
In the US as in Europe, about 9,000 people are diagnosed with STS every year and more than 4,000 die of the disease. More than half of the patients with grade 3 tumours die within 5 years of diagnosis and those with inoperable metastatic disease live on average only 8 to 12 months following diagnosis. The survival rate after 5 years of chemotherapy treatment in metastatic disease is 8%.
Isabel Lozano, chief executive officer of PharmaMar said: 'STS is an aggressive type of cancer with unfavorable prognosis and limited treatment options. The FDA's orphan drug status to Yondelis in this indication is good news for all of us and we look forward to continuing with the clinical development of Yondelis, together with our partner J&J.'