The European Medicines Agency (EMA) has awarded Adaptimmune's ADP-A2M4 PRIME status for the treatment of synovial sarcoma.
The decision provides the firm with enhanced scientific and regulatory support to accelerate the drug's development, and potentially patient access to a novel therapy where there is significant unmet need.
Soft tissue sarcomas can develop from soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. There are are 50 types different, including synovial sarcoma, which accounts for approximately 6% to 10% of all soft tissue sarcomas.
There remains a large unmet medical need for synovial sarcoma, and around one-third of synovial sarcomas occur in childhood and the peak incidence is in the third decade of life.
Access to the PRIME initiative for ADP-A2M4 was granted on the back of Phase I clinical data demonstrating “compelling efficacy and early promising durability”, with tolerable safety in patients with the disease, the firm noted.
“We are thrilled that the EMA has acknowledged the potential of ADP-A2M4 to address an unmet medical need for more effective treatment options for patients with advanced synovial sarcoma,” said Dennis Williams, Adaptimmune’s senior vice president, Late Stage Development.
“Access to the enhanced EMA support and guidance offered in the PRIME scheme will facilitate the development of ADP-A2M4 to ensure this important medicine reaches patients with sarcoma as early as possible.”