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Blood Cancers

All articles tagged with #blood cancers

FDA Warns of Increased Cancer Risk from CAR-T Therapy

Originally Published 1 year ago — by NBC News

Featured image for FDA Warns of Increased Cancer Risk from CAR-T Therapy
Source: NBC News

The FDA has instructed several drugmakers to include a boxed warning on the prescribing information for CAR-T therapy, a cancer treatment, due to reports of rare blood cancers in patients who had previously received the therapy. Despite the warning, the FDA maintains that the benefits of CAR-T therapy outweigh the potential risks. Drugmakers, including Novartis, Bristol Myers Squibb, Gilead Sciences, and Johnson & Johnson, have been directed to submit proposed label changes within 30 days. While the exact link between CAR-T therapy and cancer is not fully understood, experts believe the risk is likely very small, and the label change is expected to support physicians' discussions with patients about the potential risk of developing secondary cancers following cancer treatment.

FDA approves Omisirge cell therapy to reduce infection risk in blood cancer patients.

Originally Published 2 years ago — by FDA.gov

Featured image for FDA approves Omisirge cell therapy to reduce infection risk in blood cancer patients.
Source: FDA.gov

The FDA has approved Omisirge, a cell therapy for patients with blood cancers who are planned for umbilical cord blood transplantation following a myeloablative conditioning regimen. The therapy quickens the recovery of neutrophils and reduces the risk of infection. Omisirge is composed of human allogeneic stem cells from umbilical cord blood that are processed and cultured with nicotinamide. The safety and effectiveness of Omisirge was supported by a randomized, multicenter study comparing transplantation of Omisirge to transplantation of umbilical cord blood.