It is the first LBCL treatment to improve upon standard of care (SOC) in nearly 30 years, said developer, Gilead Sciences’ Kite Pharma.
Current SOC for patients with relapsed or refractory LBCL is high dose chemo followed by stem cell transplant. Only 30% of patients who start this process ever make it to transplant and 80% do not achieve long-term remission, said the drug maker.
The authorization from the US Food and Drug Administration (FDA) is based on data from the landmark ZUMA-7 trial and makes Yescarta (axicabtagene ciloleucel) the first and only CAR T-cell therapy approved for second-line LBCL.
The trial data demonstrated patients on Yescarta were 2.5 times more likely to be alive two years on, without cancer progression or the need for additional cancer treatment, reported the developer.
Christi Shaw, CEO of Kite, said the FDA approval brings hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. “This milestone has been years in the making.”
Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy.
CAR-T therapy rival company, Bristol Myers Squibb, is awaiting an FDA nod on its drug, Breyanzi, for the same indication; that is expected on June 24.
Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the US, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either return or become non-responsive to initial treatment.
Kite has been investing in the manufacturing process for the CAR-T therapy, looking to accelerate turnaround time. And it has been expanding capacity ahead of the FDA approval.
A spokesperson told BioPharma-Reporter:
"CAR T-cell therapy is individually made for each patient from their own T-cells and is a complex process. Manufacturing quality, reliability, and speed are critically important in CAR T-cell therapy, and patients and physicians count on Kite’s 97% reliability to return cells on time and to specification. Today, our average US production time from apheresis to product release is only 16 days, and in Europe it is 19 days - and that includes the transportation logistics to get the cells to us.
"As Kite has experienced rapid global demand for our therapies, we have invested significantly in added manufacturing capacity at our existing locations and will be bringing on-line our new Maryland manufacturing site by mid-2022 to support additional demand. We currently estimate that our manufacturing capacity will be 50% greater than it was just a year ago."
Kite also reported that Yescarta is the first CAR T-cell therapy to be listed by the US National Comprehensive Cancer Network (NCCN) in the first category of treatments for patients with relapsed or refractory LBCL.
The company said its CAR T-cell therapy products are widely covered by commercial and government insurance programs in the US. However, an ongoing challenge for the pharma group is actually getting US oncologists to refer eligible patients to hospitals that are set up to administer cell therapies, noted a Reuters story.