Porida Biologics Statement on FDA's Investigation into CAR-T Cell Therapy May Trigger T-Cell Secondary Tumors
Release time:
2023-12-01
Summary： Recently, the company was concerned about the U.S. FDA's announcement on November 28, 2023, on individual reports of T-cell tumors in patients receiving targeted BCMA or CD19 autologous CAR-T cell immunotherapy. The FDA said, "While the overall benefits of the approved uses of these products continue to exceed their potential risks, the FDA is evaluating the need for regulatory action1."
Recently, the company was concerned about the U.S. FDA's announcement on November 28, 2023, on individual reports of T-cell tumors in patients receiving targeted BCMA or CD19 autologous CAR-T cell immunotherapy. The FDA said, "While the overall benefits of the approved uses of these products continue to exceed their potential risks, the FDA is evaluating the need for regulatory action1."
Up to now, the CAR-T products developed by Porida Biology have completed the treatment of more than 800 patients in clinical trials, including more than 70 cases of targeted CD30 CAR-T products (including drug registration clinical trials), more than 600 cases of targeted CD19/CD22 sequential treatment products, and more than 100 cases of targeted BCMA CAR-T products. The above products are used in the completed pre-clinical insertion site analysis and integrated site monitoring during clinical trials, no causal relationship was found between receipt of CAR-T products and malignancy, and no CAR-positive T-cell malignancies were found in cases with long-term follow-up.
According to published information, the incidence of T-cell malignancies in patients receiving CAR-T treatment is very low. Professor Locke, Frederick of the Moffitt Cancer Center, also mentioned in an interview with MedPage Today that "the incidence of T-cell lymphoma in patients receiving CAR-T treatment is about 1 or 2 per 10,000" 2. To sum up, this incident has no impact on the company's product development and commercialization process.
Wuhan Bo Rui Da Biotechnology Co., Ltd.
December 1, 2023
References
2.https://www.medpagetoday.com/hematologyoncology/hematology/107569.
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