The Food and Drug Administration on Wednesday announced what the agency calls a “historic action” — the first approval of a cell-based gene therapy in the United States.
Researchers at Karolinska Institutet and Karolinska University Hospital have discovered that an anti-inflammatory drug candidate inhibiting the prostaglandin E2 producing enzyme mPGES-1 in the tumor stroma reduces tumor growth in experimental neuroblastoma models. The findings are published in EBioMedicine and open for new treatment strategies for this aggressive childhood cancer.
Seattle Children’s has opened the first chimeric antigen receptor (CAR) T-cell immunotherapy trial in the U.S. for children and young adults with relapsed or refractory CD19- and CD22-positive acute lymphoblastic leukemia (ALL) that will simultaneously attack two targets on cancer cells.
The Food and Drug Administration on Wednesday approved the first-ever gene therapy in the US.
CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia.
A panel of experts which advises the FDA has unanimously voted to recommend approval of a pioneering cancer therapy from Novartis.