In an advancement for cancer treatment, Gilead Sciences has received FDA approval for a new manufacturing process that accelerates the production of its revolutionary CAR-T therapy, Yescarta. Developed by Gilead’s Kite Pharma unit, this development marks a milestone...
The FDA on Monday finalized two guidance documents to help sponsors developing therapies in two crowded areas: gene therapies using genome editing and ex vivo-manufactured CAR-T cell products. The 19-page final version of the genome editing guidance is clear about the...
The proprietary process, called Ingenui-T, utilizes whole blood from a standard blood draw The novel process is designed to elevate the CAR T cell patient experience by offering a less-invasive alternative to apheresis as well as substantial reduction of cost through...
The FDA’s safety probe of CAR-T therapies has resulted in a call to add a class-wide boxed warning to these medicines, alerting patients and prescribers of their potential risk of secondary T-cell malignancies. All six commercial CAR-T therapies will be affected,...
The FDA believes that the benefit of CAR-T therapies continues to outweigh their risks amid an ongoing investigation on cases of second blood cancers developing in patients who receive the cell therapies, according to senior FDA official Peter Marks. The FDA is now...
