Phase II trial of trabectedin [ET 743] for the treatment of Japanese patients with malignant soft tissue sarcoma of histological types (chromosomal translocations)

Trial Profile

Phase II trial of trabectedin [ET 743] for the treatment of Japanese patients with malignant soft tissue sarcoma of histological types (chromosomal translocations)

Completed
Phase of Trial: Phase II

Latest Information Update: 23 May 2016

At a glance

  • Drugs Trabectedin (Primary)
  • Indications Soft tissue sarcoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Taiho Pharmaceutical
  • Most Recent Events

    • 28 Sep 2015 According to a Taiho Pharmaceutical Co., media release, trabectedin (Yondelis) received marketing approval from the MHLW for the treatment of patients with soft tissue sarcoma in Japan.
    • 01 Sep 2015 According to a PharmaMar media release, the Japanese Pharmaceutical Affairs and Food Sanitation Council (PAFSC) has recommended approval of trabectedin for the treatment of patients with soft tissue sarcoma in Japan. The PAFSC provided a positive opinion to the Japanese Ministry of Health, Labour and Welfare (MHLW) based on the review report prepared by the Japanese regulatory agency (PMDA) for trabectedin. MHLW will issue the marketing authorization based on this recommendation.
    • 21 Jun 2014 New source identified and integrated Japan Pharmaceutical Information Center: JAPIC Clinical Trials Information.
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