FDA Clears Metastatic Synovial Sarcoma Engineered Cell Therapy for Accelerated Approval

Tecelra, a product of drugmaker Adaptimmune, is a one-time only infusion therapy that uses the patient’s immune cells to go on the attack against the patient’s cancer cells. The T-cell receptor gene works against synovial sarcoma, which is a cancer affecting soft-tissue. It most often occurs in extremities.

Approximately one thousand adults in the United States., mostly under thirty years of age, will be diagnosed with the disease annually.

Dr. Peter Marks, FDA Director, explains the significance saying that synovial sarcoma is often life-threatening. The disease carries a severe impact especially in cases where standard treatment has limited efficacy as a result of tumor growth.

About SPEARHEAD-1

The FDA based its approval upon cohort 1 of the SPEARHEAD trial consisting of 44 participants who had synovial sarcoma in advanced stages. Each participant was given one treatment with the new drug, Tecelra. Overall response rates averaged 43.2% while the complete response rates were 4.5%. The median response duration was six months.

In addition, 39% showed a response that lasted a minimum of one year.
Trial investigator Dr. Sandra D’Angelo of New York’s Sloan Kettering Memorial Cancer Center was quoted in a press release saying Tecelra is significantly different from the current drugs used for synovial sarcoma’s standard of care.

Many patients who receive the standard treatment for a disease that has progressed will have a recurrence after submitting to various therapies and are left with no options. The five-year rate of survival for patients who have a disease that has metastasized is approximately 20%.

Dr. D’Angelo emphasized that the approval fills an unmet need for patients who have this sarcoma. The doctor said that it is a vital milestone for using cell therapies for solid tumor malignancies.

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Last modified: August 9, 2024