US FDA approves Adaptimmune's therapy for rare type of cancer

[August 03, 2024]  By Mariam Sunny

(Reuters) -The U.S. Food and Drug Administration said on Friday it has approved Adaptimmune's first-of-its-kind treatment for a rare type of cancer in the soft tissues that most often affects young people.

The therapy, branded as Tecelra, was approved to treat synovial sarcoma — a potentially life-threatening cancer — in certain patients who have received prior chemotherapy.

Swiss drugmaker Novartis' Votrient is among the approved treatments for soft-tissue sarcoma, a group of cancers which include synovial sarcoma. Other options include surgery, chemotherapy and radiotherapy.

Tecelra, a one-time intravenous therapy, modifies and uses a patient's own immune response generating T-cells to fight the disease. The treatment carries a list price of $727,000, the company said.

According to analysts, the price is comparable to CAR-T cell therapies, which have an average list price of $500,000.

Tecelra carries a serious warning about the risk of cytokine release syndrome, a dangerous aggressive immune system response.

Sandra D'Angelo, oncologist at Memorial Sloan Kettering Cancer Center, said therapies like Tecelra have the potential to treat other solid tumors as they could target a broader range of tumor-causing proteins than currently approved therapies.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The FDA's accelerated approval to Tecelra was based on data from a 44-patient study, in which 43.2% of the participants showed partial or complete response to the treatment for an average duration of six months.

Synovial sarcoma, which most commonly develops in the extremities, impacts about 1,000 people in the United States each year, according to the FDA.

Guggenheim analyst Michael Schmidt estimates $180 million in U.S. sales of the therapy at their peak.

Shares of the company were trading 7% down in afternoon trading. The stock has risen 46% so far this year.

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

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