News Release


 

Novel Antitumor Agent “Yondelis® IV Infusion” Approved in Japan for Treatment of Soft Tissue Sarcoma (28/09/2015)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that it has received marketing approval from the Ministry of Health, Labour and Welfare for the novel antitumor agent Yondelis (nonproprietary name: trabectedin, development code: ET-743) 0.25 mg and 1 mg IV Infusion, for the treatment of patients with soft tissue sarcoma in Japan.

Yondelis is an antitumor agent developed by the Spanish company PharmaMar, S.A. It was originally isolated from the Caribbean ascidian Ecteinascidia turbinata and is now produced through semi-synthesis. Taiho Pharmaceutical entered into a license agreement with PharmaMar in 2009 to develop and commercialize the drug in Japan, and has since been engaged in its development.

Taiho Pharmaceutical carried out three clinical trials in Japan to obtain this marketing approval. A phase I clinical trial (Clinical Trial No.10045020) designed to determine the recommended dose in soft tissue sarcoma patients was initiated in 2010. This was followed by two Phase II trials in soft tissue sarcoma patients with histological types*1 reported to have chromosomal translocations. One trial (Clinical Trial No.10045030) was a randomized phase II trial which compared progression-free survival (PFS) between ET-743 arm and Best Supportive Care (BSC) arm. The other (Clinical Trial No.10045040) was a Phase II trial designed to evaluate the safety of the drug. In this trial, subjects assigned to the BSC arm in trial 10045030 but who were discontinued due to disease progression, were administered ET-743. The results of trial 10045030 demonstrated the clinical efficacy of ET-743, with an improved PFS in patients treated with ET-743 compared to BSC, and an manageable safety profile with adverse drug reactions that were controllable with appropriate measures, such as temporary dose discontinuation, dose reduction, and supportive care treatment. ET-743 has been designated as an orphan drug in June 2011, in Japan.

Taiho Pharmaceutical believes that Yondelis will contribute to the treatment of patients, as a new treatment option for soft tissue sarcoma, an area of unmet medical needs.

About soft tissue sarcoma
Soft tissue sarcoma is an intractable malignancy which develops in the soft tissues (muscles, connective tissues, fat, blood and lymph vessels, etc.) of the body. In Japan, the annual incidence rate is about 2~3 cases per 100,000 population, and it is an orphan disease with an estimated patient number of 5,000.*2

About Yondelis
Yondelis was originally isolated from the Caribbean tunicate Ecteinascidia turbinata and is now produced synthetically. It is an antitumor agent that binds to DNA, where it interferes with cell division, the transcription process, and the DNA repair machinery.
In September 2007 it was first approved in the EU for the treatment of advanced soft tissue sarcoma in adults for whom anthracyclines and ifosfamide were not effective or for whom administration of those drugs is not recommended. It is currently approved in 77 regions and countries*3 worldwide, including Europe, South America and Asia.

About PharmaMar
Headquartered in Madrid, Spain, PharmaMar is the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis in Europe for the treatment of advanced soft-tissue sarcomas and for relapsed platinum-sensitive ovarian cancer, and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States.


*1. Presence of fusion genes and tumor-specific chromosomal translocations has been reported in some soft tissue sarcomas. Chromosomal translocations occur when chromosomes break and the fragments fuse to other chromosomes. It is thought that the fusion genes occurring from this chromosomal translocation might be the cause of certain malignancies.
*2. Calculated by subtracting 1,000 “mesothelioma” patients from the 6,000 “malignance of mesothelioma and soft tissue” patients, referencing the MHLW Patient Survey (2011).
*3. As of July, 2015
 

 

Summary of the Approval

 

Brand name: Yondelis®0.25 mg and 1 mg IV Infusion

Nonproprietary name: trabectedin

Indication: Soft tissue sarcoma

Dosage and administration : in adults, trabectedin is normally administered via intravenous infusion in a dose of 1.2 mg/m2 per administration over 24 hours with at least 20 days of rest. This constitutes one repeatable cycle.

The dose may be reduced based on the patient’s condition.


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