FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor
Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma.
Tecelra’s approval comes with several firsts. It’s the first engineered cell therapy for a solid tumor, the first TCR-T therapy to enter the market, and the first new treatment in the indication in more than a decade.
It also is the initial approval for the 16-year-old company, which has attracted and lost partnerships with several pharma giants—including GSK, Astellas and most recently Roche—who were drawn to the potential of Adaptimmune’s unique engineered T-cell receptor (TCR) platform. It enables the engineering of T-cells to target and destroy many types of solid tumor cancers.
As the first engineered T-cell therapy for solid tumors, Tecelra marks a significant milestone, not only for the company but also for the advancement of cell therapy.
“It’s the first product where we use a lentiviral vector to insert our engineered T-cell receptor into the cell,” John Lunger, Adaptimmune’s chief patient supply officer, explained in an interview. Iovance’s Amtagvi (lifileucel), which was approved by the FDA in February for melanoma, was the first T-cell treatment for solid tumors. The difference with Tecelra is that it is engineered.
Amtagvi uses immune cells, called tumor-infiltrating lymphocytes (TILs), which are collected from a patient’s tumor, as opposed to CAR-T cell therapies, which are collected from a patient’s circulating blood.
“Ninety percent of cancer is solid tumors,” Lunger said. “The idea of a company like ourselves, going after solid tumors using cells, we’re finally getting to that place where we’re demonstrating this can actually work.”
The list price for the one-time therapy is $727,000. The addressable patient population in the US is roughly 400 per year, Lunger said.
Sarcomas are rare solid tumor cancers that develop in the bones and soft tissues including fat, muscle, nerves and blood vessels, which often strike young adults. Of the roughly 13,400 new soft tissue sarcomas diagnosed annually in the US, 5 to 10% are of the synovial type. The five-year survival rate is 20%, with most patients going through multiple lines of therapy, Adaptimmune said.
August 5, 2024
