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news.The US Food and Drug Administration (FDA) has granted priority review for PharmaMar's new drug application (NDA) for Yondelis (trabectedin) to treat patients with advanced soft tissue sarcomas (STS).
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The drug is indicated to treat patients with STS, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
STS are a type of cancer originating in the soft tissues such as muscle, fat, blood vessels, nerves, tendons and the lining of joints.
The NDA was submitted in November 2014 by PharmaMar’s strategic partner Janssen Research & Development responsible for the development of Yondelis in the US.
The drug secured orphan drug designation for STS by the European Commission in 2001 and by the FDA in 2004.
Yondelis is a new, multimodal, synthetically produced anti-cancer agent, and originally derived from the sea squirt and it prevents tumor progression via different mechanisms of action such as DNA binding to block its replication, inhibition of activated transcription and proteins involved in DNA repair, and the modulation of the tumor microenvironment.
Janssen secured license from PharmaMar to develop and sell Yondelis globally except in Europe and Japan.
Currently, Yondelis is commercialized in 77 countries to treat advanced STS as single-agent, and in 70 countries for relapsed platinum-sensitive ovarian cancer in combination with pegylated liposomal doxorubicin.