The U.S. Food and Drug Administration is currently investigating the phenomenon of people developing another cancer after receiving advanced cancer**. Known as CAR-T cells, these are based on the principle of extracting immune cells (T cells) from the patient's body and tweaking their genes so that they can track and attack cancer. Since 2017, the U.S. Food and Drug Administration has approved six drugs for blood cancers such as leukemia and lymphoma. Scientists are also experimenting with CAR-T cells** for other cancers and immune system problems. The U.S. Food and Drug Administration is currently investigating the safety of this ** to ensure that patients can accept that it is effective** without other health problems.
The department is currently investigating cases of T cells turning into cancer cells in patients who received this **. On Tuesday, the U.S. Food and Drug Administration is considering the need for public regulation and cited a number of cases of patients being hospitalized or dying after **. CAR-T cells** are often the last resort after traditional methods such as chemotherapy and radiation have failed. While CAR-T cells are not necessarily a perfect method, they work very well against serious cancers. Depending on the type of cancer, more than two-thirds of patients who receive CAR-T cells*** will go into remission. Currently, experts are working to understand why this type of T cell metastasis occurs in some patients and to ensure the safety and efficacy of **.
The development of CAR-T cells** can be traced back six years. Kimuria was the first CAR-T cell to be recognized and make headlines**. At the time, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb said:"By taming patients' own cells to fight deadly cancers, we are entering a new frontier of medical innovation. kymriah to 47A staggering $50,000** was introduced to the market, followed by other new CAR-T cells** that were subsequently approved and marketed in similar ways**. For oncologist and blood cancer specialist David Porter, the FDA's announcement came as a big surprise. The University of Pennsylvania has not yet encountered a case of T cells turning into cancer cells after **. The University of Pennsylvania has used more than 800 patients with CAR-T cells*** and hundreds of patients with commercially available CAR-T cells***. For the case of post-T cell cancer, experts now need to conduct more in-depth studies to ensure the safety and efficacy of the post-T cell cancer.
Scientists use harmless viruses whose natural properties allow them to deliver and implant new genetic material into cells. However, the use of these viruses also has the potential to cause new cancers unexpectedly, which has been a theoretical issue that has been considered. The U.S. Food and Drug Administration mentioned in its announcement that the use of these viruses may increase the incidence of cancer in patients. One of the disadvantages of using viruses is that they often insert genetic material into the human genome at will, and exactly which genes they bind with depends on where this new genetic material is incorporated, which may activate nearby cancer genes. Porter said:"The concern is that the introduction of new genetic material into a patient's T cells may induce these cells to become cancerous"。
Given this risk, the U.S. Food and Drug Administration requires patients receiving CAR-T cells** to be monitored for up to 15 years. In a statement released this Tuesday, the FDA advised:"Patients and those undergoing these ** clinical trials should be closely monitored for the rest of their lives in case of potential new cancers"。
Another possibility is that early-stage cancers** such as chemotherapy and radiation may lead to the emergence of new T-cell cancers. The purpose of these is to destroy cancer cells, but they also damage the DNA of healthy cells. This damage to DNA can lead to mutations in cells that can eventually lead to cancer. In general, cancer does not end with a single mutation. As a result, previous chemotherapy or radiation therapy may have damaged the cell's DNA, making it more susceptible. If a cell has undergone other mutational events, it has already set itself on the path to cancer"。
A Bristol-Myers Squibb spokesperson acknowledged the FDA's investigation. The company is the manufacturer of CAR-T cells **Abecma and Breyanzi. More than 4,700 patients received these**, some of which were part of research trials and others were commercial products. To date, Bristol-Myers Squibb has not identified any cases of CAR-positive T-cell malignancies, nor has it found a direct link between our products and secondary malignancies.
Johnson & Johnson is the manufacturer of Calvicti, another ** method approved by the U.S. Food and Drug Administration (FDA). A spokesperson representing Johnson & Johnson expressed the company's commitment to patient health and safety. The spokesman said"We have shared data with the FDA and are working with them to investigate this newly discovered security issue"。According to the spokesperson, more than 2,000 patients have already received Carvykti's **. Kitepharma, a Gilead subsidiary, manufactures two other over-the-counter** drugs, Tecatos and Yescarta. In response to an email inquiry, a Gilead representative said the company was confident in the product's safety and had treated 17,700 patients. The Representative clarified"To date, we have found no evidence of a causal relationship between the use of Eascarta or Tecatos and the occurrence of these T cell-derived malignancies"。He also highlighted Gilead's rigorous security monitoring procedures and said the company works closely with the FDA on product data.
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