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Meta-Analysis Questions FDA Warning on Secondary Cancer Risks With CAR T-Cell Therapies
Researchers analyzed two dozen studies and found similar rates of second primary cancers in patients receiving CAR T-cell and standard therapies.
NICE Recommends Novartis' Kymriah for Pediatric Acute Lymphoblastic Leukemia
The institute inked a deal with Novartis to provide the CAR T-cell therapy in the NHS at a discount to patients up to age 25 with relapsed B-cell ALL.
FDA Publishes Letter to Novartis Detailing Kymriah Manufacturing Safety Concerns
In the letter, which the agency sent to Novartis in August, FDA inspectors referenced contaminated batches of the cell therapy product and moldy facilities.
Next-Gen Cell Therapies Bedeviled by Regulatory Murkiness on Product Characterization, Manufacturing
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At a recent Friends of Cancer Research meeting, drugmakers and regulators said communication has improved on cell therapy development programs but acknowledged persistent challenges.
Investigators in Shanghai saw a 99 percent complete response rate among advanced B-ALL patients receiving two populations of autologous CAR T cells at once.