Johnson anti-tumor drug Yondelis heavy granted after a lapse of six years

Drug development is a long process, from pre-clinical to clinical research will experience a considerable period of time. However, faced with strict examination and approval of the relevant medical management department, drug development cycle will be longer even in the foreseeable future. Faced with this situation, many pharmaceutical companies adhere to teeth only select this approval marathon.
Johnson & Johnson recently announced the development of anti-cancer drug Yondelis has been approved by the US FDA for the treatment of soft tissue sarcoma. This marks Yondelis three occasions, approval was finally ended the marathon continued for six years. FDA said that the future Yondelis will be approved for the treatment can not be removed by surgery and chemotherapy liposarcoma and leiomyosarcoma patient tolerance type.
This approval is based on the latest phase III clinical study results submitted by Johnson & Johnson. In this there are 518 patients involved in the study, compared to conventional chemotherapy dacarbazine, Yondelis can significantly prolong the survival of patients.
For Johnson & Johnson, the approval of Yondelis is undoubtedly the end of a painful journey.
In 2001, Johnson & Johnson is obtained from the Spanish pharmaceutical company Zeltia authorization of this drug, and began Yondelis in ovarian cancer. In 2009, FDA because of security problems and the effect is not too significant and other reasons rejected the listing application Yondelis and Doxil combination therapy. Two years later the same reason, Johnson was forced to suspend the project and turn malignant sarcoma research and development.
Earlier, at Zeltia companies and other partners efforts, Yondelis has been successfully listed on the world's countries and regions. And after a lapse of six years, Yondelis is approved in the US market is undoubtedly an important supplement to the drug market. After a marathon six years, holding exclusive rights to sell Yondelis US market will probably sigh of Johnson & Johnson.
Johnson & Johnson said that soft tissue sarcoma is a rare malignant tumor, about five thousand people die each year of diseases. The two approved indications Yondelis is a higher degree of malignancy of this tumor type.