US FDA approves Adaptimmune’s gene therapy for rare type of cancer, ET HealthWorld

London: The U.S. Food and Drug Administration said on Friday it has approved Adaptimmune’s first-of-its-kind gene therapy to treat a rare type of cancer in the soft tissues, which typically affects young men.

Branded as Tecelra, it was approved to treat synovial sarcoma in certain patients who have received prior chemotherapy.

The company said the treatment would launch at a list price of $727,000.

It is the first gene therapy to be approved in the United States that uses a patient’s own immune response generating T-cells to fight the cancer.

Tecelra, administered as a single intravenous dose, was given an accelerated approval, which requires the company to verify its benefit in a confirmatory trial.

Synovial sarcoma, which most commonly develops in the extremities, impacts about 1,000 people in the United States each year and most often affects adult males in their 30s or younger, according to the FDA.

Shares of the company fell 3.5 per cent to $1.23 in early trading.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)