A recent decision by the U.S. Food and Drug Administration, the country’s main health regulator, has provided approval to a CAR-T therapy that was developed between Johnson & Johnson as well as the China-focused business partner Legend Biotech Corporation. The therapy has been developed to help treat a specific variety of white blood cell cancer, the U.S.-based healthcare and pharmaceutical company has announced.
The decision by the U.S. Food and Drug Administration has created a solid path for Legend Biotech’s first FDA-approved product to be marketed and sold in the United States. This is happening at a time when the FDA has increased its overall scrutiny of drug trials that have taken place in China. The testing for the joint Legend Biotech and Johnson & Johnson therapy was initially tested in China, with further trials taking place in Japan and the United States.
Initial reactions to the approval were promising for the transnational partnership. “This is the first of many cell therapies we plan to bring to patients as we continue advancing our pipeline across disease states,” said Ying Huang, who is both Legend’s chief executive officer as well as its chief financial officer. The treatment, known as Carvykti or Cilta-cel, is part of a newer class of medications that are known as chimeric antigen receptor T-cell therapies, or CAR-T therapies.
These types of CAR-T therapy medications work by first harvesting the patient’s T-cells, which fight disease within the body. The harvested T-cells are then genetically engineered so that they will focus on targeting particular proteins located on and in cancer cells for this type of disease. Once they’ve found the cancer cells that they are targeting, the genetically modified T-cells will then attack the cancer cells, reducing spread.
The companies will sell the new CAR-T therapy in greater China using a 70/30 profit split to favor Legend Biotech, with a 50/50 split in profits in all other countries. The decision on the partnership’s CAR-T therapy was originally expected back at the end of November following priority review six months before, but the agency requested an additional three months of review time to be able to go over all of the submitted information after the FDA requested additional information from Johnson & Johnson.
Legend Biotech began the partnership by agreeing to a contract with Janssen Biotech Inc., which is an arm of the Johnson & Johnson family of companies. This started back in 2017, at which point Johnson & Johnson provided Legend Biotech with a $350 million payment upfront, while partnering with the firm to develop and commercialize the drug jointly.
Beyond the U.S. Food and Drug Administration approval, Carvykti and Cilta-cel is also under review by healthcare and pharmaceutical authorities in both Europe as well as Japan. It’s expected that given the additional profitability percentage in China that Legend Biotech will handle the Marketing Authorization Application for the therapy in that country, though it has yet to be filed there.
