On August 30, 2017, the US Food and Drug Administration approved the very first Chimeric Antigen Receptor T-cell therapy (CAR T-cell), tisagenlecleucel (KymriahTM), for treatment of pediatric and young adult Acute Lymphoblastic Leukemia. Eight years subsequently, we have witnessed tremendous advancements of immunotherapy in basic research and their breakthrough into clinical trials.
This is evident from the observation that seven CAR T-cell based cancer therapies were approved in the US in 2024 alone. Furthermore, there are over 1,000 clinical trials ongoing worldwide, in various stages, exploring this exciting technology for the treatment of diverse tumor types.
Mary McGann, PharmD, BCOP – a clinical pharmacy specialist in bone marrow transplant and cellular therapy – told Pharmacy Practice News, it’s “Definitely an exciting time. I feel like every year we almost double the number of CAR-T patients that we have.”
With the FDA having approved an additional six CAR T-cell treatments for use in qualified patients to date, the global market for CAR T-cell therapies is expected to reach at least $27 billion by 2033.
Amongst the companies participating in clinical trials right now, Cytomed Therapeutics (NASDAQ: GDTC) is exploring the use of its products as an “off-the-shelf” allogeneic cellular immunotherapy to be used for a broad spectrum of cancers.
Unlike most CAR T-cell therapies, CytoMed’s products aim to use healthy donor cells, rather than cells from compromised patients, to engineer the therapy by developing a single allogeneic product for the treatment of a wide array of cancers.
The company has an ongoing clinical trial currently in Singapore, with and an upcoming trial in India.
Cytomed Therapeutics’ Chairman, Peter Choo, said of the global increase in clinical trials and FDA approvals, “The science behind CAR T-cell therapies has shown to be a real-life saver. It is exciting to see the US FDA finally taking notice of its promise.
“While we are currently involved in two separate trials, we do believe this year, 2025, could very well prove to be the year where we, and the industry as a whole, are proven to not only be viable, but essential in the global fight against cancer.
“Further, our products, as a differentiator, look to treat a multitude of tumors, both solid and liquid, via commercial production, and to do so at a much lower cost than current therapies.
“By achieving this, we believe we could open up treatment for far more patients, with hopes of saving far more lives.”
With the large number of CAR T-cell therapies currently in clinical trials, the outlook for 2025 is very bright. However, the average cost per patient for CAR T-cell therapy in the United States often exceeds $400,000.
The key to real success, outside of patient remission, will be, as Mr. Choo believes, bringing the cost of CAR T-cell therapies down significantly, which is CytoMed’s core approach with its technology.
Read more about CytoMed Therapeutics’ pipeline, HERE
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