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On November 28, the U.S. FDA announced: It is investigating the "serious risk" of malignancies in patients who have received CAR-T therapies targeting BCMA or CD19.
The regulatory agency stated that the products under investigation include: Bristol-Myers Squibb'sAbecma and Breyanzi, respectively used for the treatment of multiple myeloma and large B-cell lymphoma; Johnson & Johnson'sCarvykti, used for the treatment of relapsed/refractory multiple myeloma; Novartis'Kymariah, used to treat lymphoma in adults and children; Kite Pharma, a subsidiary of Gilead Sciences.Tecartus and Yescarta, used to treat leukemia and lymphoma.
The FDA stated that it has received clinical trial reports and post-market adverse event data, with cases of T-cell malignancies reported in patients treated with these products.In this regard, spokespersons from various companies responded.Spokesperson for Gilead's Kite"We are confident in the overall safety of Tecartus and Yescarta."To date, whether in clinical trials or commercial settings, we have treated 17,700 patients. So far, there is no evidence to suggest a causal relationship between Yescarta or Tecartus and the development of new malignancies. We have stringent procedures in place to monitor and report adverse events to regulatory authorities. Gilead has fully cooperated with the FDA’s requests to analyze data related to this investigation.Novartis spokespersonStated: As part of its "ongoing safety monitoring," the company has not yet established a causal relationship between Kymriah and secondary malignancies.Johnson & Johnson SpokespersonPointed out: As part of the safety monitoring following CAR-T therapy treatment, the FDA requires secondary/primary malignancy testing for patients who have received the therapy in both clinical research and commercial settings. Currently, the company has shared data with the FDA and is collaborating with the agency to evaluate the therapy's safety. It was also noted that globally, more than 2,000 patients have received Carvykti treatment, and the overall benefit-risk profile "remains favorable."BMS"In a statement, it was noted: 'More than 4,700 patients have been treated with the company’s Abecma and Breyanzi in clinical and commercial settings. To date, BMS has not identified any cases of malignant tumors. Therefore, we have not found a causal relationship between our products and secondary malignancies. Patient safety remains BMS's top priority, and we continue to have confidence in the safety and clinical value of our cell therapies.'""One of the original developers of CAR-T technology, Professor Carl June from the University of Pennsylvania, stated, 'These are early reports of the first cases of autologous T-cell transformation. Scientifically, it is important to understand whether these cases had pre-existing clonal hematopoiesis that could lead to such adverse events. Prior treatment with cytotoxic chemotherapy might make patients more susceptible to such incidents.'"https://www.biospace.com/article/fda-launches-probe-of-malignancies-linked-to-car-t-therapies-/
