MHLW Delays Trabectedin Approval
This article was originally published in PharmAsia News
Executive Summary
A working group of Japan's Ministry of Health, Labor and Welfare on unapproved drugs has delayed approving soft tissue sarcoma drug Yondelisa (trabectedin), developed by Spanish pharmaceutical company Zeltia's subsidiary PharmaMar. MHLW cited a lack of testing data and unconfirmed targeting of patients and said it awaits the release of further data. Trabectedin was approved by EMEA last July, and has yet to be approved by FDA
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