Gilead ramping up CAR T clinics after US FDA Yescarta approval
This week, Gilead Sciences became the second company to receive approval for a chimeric antigen receptor T cell (CAR T) therapy after the US Food and Drug Administration (FDA) gave Yescarta the nod for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.
Gilead acquired the product in August through its $11.9bn acquisition of Kite Pharma.
The product is made by isolating peripheral blood mononuclear cells, including T-cells, from the patient’s own white blood cells. These are then sent to a facility in El Segundo, California – which Kite opened in June last year – where they are stimulated to proliferate and transduced with a retroviral vector to introduce the CAR sequence into the patient’s T cells before being propagated in cell culture bags.
Once there are a sufficient number of cells available for infusion back into the patient, they are washed and frozen at the cell processing site before being shipped back to the clinical centre where they can be administered to the patient. The process takes an average of 17 days from receipt of the patient’s white blood cells.
The manufacturing site has capacity to produce volumes of the autologous therapy for 4,000-5,000 patients per year, but now Yescarta has been approved Gilead said it is looking to ramp up the number of clinics available to administer the therapy.
“We are working to certify 16 leading cancer centers in 13 states to administer Yescarta,” Gilead spokesperson Sonia Choi told Biopharma-Reporter.
“Given the exciting promise of CAR T therapy and patient need, we are actively working with more than 30 additional institutions, bringing them through our site readiness process – a process that will continue until we reach our ultimate target of 70 to 90 academic centers.”
Novartis became the first company to receive US approval for a CAR T therapy in August but was criticised by some by pricing Kymriah (tisagenlecleucel) at $475,000. The Swiss Biopharma argued it could have charged as much as $750,000 but the lower price tag would “support sustainability of the healthcare system and patient access” while allowing a return on investment.
Gilead has set the list price of Yescarta at $373,000 for the single treatment, over $100,000 less than Kymriah.
According to Choi, “[Gilead] conducted extensive research with commercial and government payers, as well as targeted cancer centers, to set a price that reflects the value represented by this innovation, and that supports accessibility of this personalised therapy.”