Updated on 30 September 2015
Madrid-headquartered PharmaMar announced that its partner in Japan, Taiho Pharmaceutical has received marketing approval for Yondelis (trabectedin) by the Japanese Minister of Health, Labour and Welfare for the treatment of patients with soft tissue sarcoma. The indication includes all types of soft tissue sarcoma.
PharmaMar indicates that this approval is based on the positive results from a multicenter, randomized, open-label phase II trial in soft tissue sarcoma patients that had chromosomal translocations to compare trabectedin treatment against best supportive care (BSC). Progression-free survival (PFS) was the primary endpoint, which was measured by central radiology review that allows a uniform process of evaluation across centers and patients.
Trabectedin treatment reduced the risk of disease progression compared to BSC, achieving a median PFS of 5.6 months for patients treated with trabectedin compared to 0.9 months for the BSC group.
Commenting on the approval Luis Mora, Managing Director of PharmaMar said, "We are very excited to witness the approval of Yondelis in Japan, so this drug can be available to patients with a disease that remains an unmet medical need in Japan. Collaborating with Taiho was crucial to bring this product to the oncology community in Japan."
For the approval of Yondelis in Japan, PharmaMar will receive two payments, 600 million Japanese yen from Taiho Pharmaceutical and $5 million from Janssen Products.