Janssen Research & Development is seeking approval from US Food and Drug Administration (FDA) for its Yondelis (trabectedin) to treat patients with advanced soft tissue sarcoma (STS).
A new drug application (NDA) was submitted by the company for the drug to treat patients with advanced STS.
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This includes liposarcoma and leiomyosarcoma subtypes, who received prior chemotherapy including an anthracycline.
Yondelis is a multimodal and synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata.
Janssen Research & Development global oncology head Peter Lebowitz said: “We are particularly proud of this filing, as it represents our commitment to Yondelis and the people it may help.
“The advanced soft tissue sarcoma treatment landscape has been relatively stagnant for decades and it’s our hope that Yondelis will be a new treatment option for people living with this aggressive disease.”
Janssen also unveiled plans to amend protocol for the Phase III randomised open-label study ET743-SAR-3007, on which the NDA submission is based.
The trial is assessing the safety and efficacy of trabectedin against dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma in 500 patients, previously treated with an anthracycline and ifosfamide or an anthracycline followed by one additional line of chemotherapy.
The anti-cancer medicine, which works by preventing tumor cells from multiplying, is approved in 76 countries in North America, Europe, South America and Asia to treat advanced STS as a single-agent.
It is approved in 69 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection).
Janssen Products holds the rights to develop and sell Yondelis globally except in Europe, under a licensing agreement with Zeltia Group’s wholly-owned member, PharmaMar. Yondelis will be commercialised by Janssen Biotech, if approved in the US.
Image: Labelled CT image of undifferentiated soft tissue sarcoma in left lung of a young child. Photo: courtesy of ThatPeskyCommoner.
