Gilead’s CAR-T therapy Yescarta (Axicabtagene ciloleucel) has been recommended for routine use on the National Health Service (NHS) in England for patients with an aggressive form of lymphoma.
The US Food and Drug Administration (FDA) has approved Kite’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
Kite says a two-year retrospective analysis of the commercial manufacturing and supply of its CAR T therapy, axicabtagene ciloleucel (Yescarta), shows a high manufacturing success rate and a reliable turnaround time.
As we have entered the summer, companies have taken to refreshing their leadership positions, including at companies such as Gilead, Alnylam, and Maze Therapeutics.
The difficulties in the manufacture of CAR-T treatments have become increasingly understood as the breakthrough technology has been commercialised, but Kite’s head of medical affairs says its process is nearly flawless.
MaxCyte announces a partnership with Kite to explore the use of flow electroporation technology to enable the non-viral cell engineering of CAR-T drug candidates.
Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
