FDA Approves Yescarta:From Breakthrough Therapy to Optimized Manufacturing and Broader Indications
FDA Approves Yescarta:From Breakthrough Therapy to Optimized Manufacturing and Broader Indications
FDA Approves Yescarta for Large B-Cell Lymphoma
On October 18, 2017, the U.S. FDA approved the CAR-T cell therapy Yescarta for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Yescarta was the first CAR-T therapy approved by the FDA for the treatment of non-Hodgkin lymphoma and the second CAR-T cell therapy to be approved.
FDA Approves Yescarta for Relapsed/Refractory Follicular Lymphoma
On March 5, 2021, the U.S. FDA granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This represented the first CAR-T cell therapy approved for the treatment of indolent follicular lymphoma. It was also the third approved indication for Yescarta.
FDA Approves Yescarta as Second-Line Treatment for Relapsed Large B-Cell Lymphoma
On April 1, 2022, the FDA approved a new second-line indication for Axicabtagene Ciloleucel (Yescarta, Axi-Cel) for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. This indication does not include patients with primary central nervous system lymphoma.
FDA Approves Manufacturing Process Change for Yescarta
On January 30, 2024, Kite, a Gilead company, announced that the U.S. FDA has approved a manufacturing process change for the CAR-T cell therapy Yescarta. According to Chris McDonald, Head of Technical Operations at Kite, this approval reduces the manufacturing time for Yescarta CAR-T cells from an average of 7 days to 5 days.
Due to the reduced manufacturing time, Kite will be able to shorten the median turnaround time for Yescarta (from the collection of a patient’s T cells to the release of the final product) from 16 days to 14 days.
This manufacturing upgrade comes as Kite is aggressively positioning Yescarta as a second-line therapy for large B-cell lymphoma. Last month, the FDA allowed the addition of further patient survival data to Yescarta’s label, demonstrating a 27.4% reduction in the risk of death compared to standard of care in the Phase 3 ZUMA-7 trial.
“For patients with relapsed or refractory large B-cell lymphoma, every day matters as their disease progresses rapidly. This FDA approval further shortens the delivery time for Yescarta, increasing the potential for better outcomes for these patients,” said Cindy Perettie, Executive Vice President at Kite.
In terms of product delivery efficiency, Yescarta holds an advantage over Bristol Myers Squibb’s competing product Breyanzi. Yescarta currently has a median turnaround time of 14 days, compared to 24 days for BMS’s Breyanzi.
Kite currently manufactures and commercializes CAR-T therapies at two U.S. facilities, one in El Segundo, California, and another in Frederick, Maryland, along with a European facility in Amsterdam. Additionally, Kite self-supplies viral vector from a facility in Oceanside, California.
If possible, Kite aims to quadruple its capacity based on its existing infrastructure.
Furthermore, Kite has over 400 authorized treatment centers (ATCs) globally, with over 135 ATCs in the United States.
Through these ATCs, more than 17,700 patients globally have received Kite’s CAR-T therapies. Kite continues to increase its manufacturing capacity to meet the growing clinical demand.
The price of yescarta is 373000 US dollars in the United States and 1.2 million RMB in China.