Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.
Adaptimmune Therapeutics announced late Thursday that the FDA has approved afamitresgene autoleucel—now to carry the brand name Tecelra—for the treatment of unresectable or metastatic synovial sarcoma.
Tecelra is the first engineered T cell therapy for solid tumor cancers in the U.S. and is the first new therapeutic option for synovial sarcoma in a more than 10 years, according to Adaptimmune. Tecelra was approved under the FDA’s accelerated pathway and Adaptimmune will need to verify its clinical benefit in a confirmatory trial to keep the product on the market.
CEO Adrian Rawcliffe in a statement called Tecelra’s approval a “momentous step” toward the company’s goal to “redefine the way cancer is treated.” Adaptimmune plans to sustain its pipeline’s momentum with its late-stage sarcoma therapy lete-cel, for which it will start a rolling Biologics License Application next year, Rawcliffe said.
Adaptimmune has yet to reveal its pricing structure for Tecelra but Graig Suvannevejh, senior biopharma and biotech equity research analyst at Mizuho Americas, told BioSpace in an interview on Monday that peak sales for Tecelra and lete-cel could reach around $400 million per year.
Still, revenue from the newly approved therapy might not immediately reflect on Adaptimmune’s balance sheet until the third or fourth quarter of 2025, Suvannevejh said, explaining that this delay is due to the complexities of marketing cell therapies.
Designed to be a one-time therapy, Tecelra is an engineered T cell therapy that makes use of a patient’s own immune cells and modifies them to be able to target cancer cells. Tecelra is designed to recognize and attack the melanoma-associated antigen A4 (MAGE-A4) protein, which is crucial to preventing cell cycle arrest and cell death. MAGE-A4 is commonly overexpressed in solid tumors, especially synovial sarcoma.
When activated after binding to MAGE-4, Tecelra induces the proliferation of T cells and secretion of cytokines, leading to the destruction of cancer cells expressing the antigen, according to its label.
Tecelra’s approval is based on data from the SPEARHEAD-1 study, which found an overall response rate of 43% in patients treated with the T-cell therapy. Complete response was reported in 4.5% of patients. Treatment response lasted for at least 12 months in 39% of study participants who were responsive to the therapy.
Tecelra carries a boxed warning for cytokine release syndrome (CRS), which could become severe or life-threatening, according to its label. Patients should be evaluated for hospitalization, institute-based treatment and supportive care “at the first sign of CRS.”
