The U.S. health regulator has approved a therapy developed by Johnson & Johnson and its China-focused partner Legend Biotech to treat a type of white blood cell cancer, the U.S. healthcare company said on Monday.
The Food and Drug Administration's decision paves the way for Legend's first approved product in the United States, at a time when the regulator has stepped up its scrutiny of drug trials conducted in China. The Legend-J&J therapy was tested initially in China, and then in the United States and Japan.
"This approval of Janssen's first cell therapy is a testament to our continuing commitment in oncology to deliver new therapeutic options and drive toward our vision of the elimination of cancer," said Mathai Mammen, executive vice-president, pharmaceuticals, Janssen Research & Development at Johnson & Johnson.
The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell therapies.
CAR-T drugs work by harvesting a patient's own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.