FDA grants first US approval for engineered cell therapy to treat solid tumors

The FDA approved the firm’s new cell therapy specifically to treat synovial sarcoma in adults with certain HLA types and whose tumor expresses the MAGE-A4 antigen. Those treated must have also previously undergone chemotherapy treatment. According to Adrian Rawcliffe, CEO of Adaptimmune, Tecelra is the first new treatment option for synovial sarcoma to be approved in over a decade.

Synovial sarcoma is a rare type of cancer that most frequently affects adult males under 40. It occurs primarily in soft tissue near the extremities, but it has been documented in many human tissues, including organs.

In a conference call today, Rawcliffe announced that Tecelra will launch at a list price of $727,000. The first commercial sales of the new therapy are expected during the fourth quarter of this year.

The firm has prepared to administer the autologous T cell immunotherapy at six to ten authorized treatment centers (ATCs) in the coming months. Most of those sites were used during clinical trials and are being prepared for commercial application.

The company will subsequently expand to 30 ATCs within the next two years. Rawcliffe said that doing so will enable Adaptimmune to supply every eligible patient in the United States.

The approval follows Tecelra’s SPEARHEAD-1 clinical trial, which showed an overall response rate (ORR) of 43% with a complete response rate of 4.5%. Sandra D’Angelo, SPEARHEAD-trial principal investigator, said that the therapy “uses each patient’s own immune cells to recognize and attack their cancer cells in a one-time infusion treatment.” She added that it is “significantly different [from] the current standards of care for advanced synovial sarcoma. This approval represents a much-needed new option for people diagnosed with this sarcoma and an important milestone for the use of cell therapies in solid tumor cancers.”

“We manufactured every single dose of afami-cel for the SPEARHEAD-1 clinical trial in our manufacturing facility here in Philadelphia, [Pennsylvania’s,] Navy Yard over the five years of the trial,” Rawcliffe said on the call. He announced that Adaptimmune has bolstered its manufacturing infrastructure and that the company is prepared to “deliver all ordered commercial doses of Tecelra.”

Although Rawcliffe acknowledged Tecelra’s potential to expand into Europe and even into other indications, he emphasized that the company’s only focus is on bringing the therapy to US patients under its current approval.