Gilead’s Kite Pharma has secured FDA approval for an improved manufacturing process of its CAR-T therapy, Yescarta, accelerating the treatment’s production timeline

This accelerated timeline is crucial for patients battling large B-cell lymphoma, as Cindy Perettie, head of the Gilead cell therapy business, emphasizes the urgency of treatment due to the aggressive nature of the disease. The reduced wait time for Yescarta could potentially be lifesaving for many patients, providing them with faster access to this vital therapy.

Yescarta has already been making waves in the market, notably outpacing Bristol Myers Squibb’s rival drug, Breyanzi, in terms of product delivery efficiency. With the latest manufacturing improvements, Yescarta sets a new industry benchmark with its 14-day median turnaround time, significantly shorter than the 24 days targeted by Breyanzi.

However, the impact of manufacturing time on patient treatment is profound. Clinical trials have shown that the time taken to produce individualized therapies can result in disease progression for some patients while they wait. In Gilead’s ZUMA-7 trial, for instance, a small proportion of patients could not receive Yescarta due to the advancement of their condition during the manufacturing period.

Experts in the field, like David Porter from Penn Medicine, acknowledge the importance of these advancements. While he suggests that the reduction from 16 to 14 days might not be a major clinical leap, he agrees that any reduction in time is beneficial in preventing cancer progression.

Behind the scenes, this manufacturing efficiency is driven by Gilead and Kite’s efforts to optimize their processes, aiming to reduce quality control testing and processing steps. Chris McDonald, Kite’s global head of technical operations, points out that these enhancements are expected to lower overall costs and boost manufacturing capacity at their facilities in the United States. However, the specifics of these process improvements remain confidential, part of Gilead and Kite’s strategy to maintain their competitive edge.

While this update currently applies only within the United States, with international implementation pending additional regulatory approvals, it represents a significant stride in CAR-T therapy. Before this update, Gilead was already leading the race with the fastest turnaround times for its cell therapies, including Yescarta and Tecartus.

As the field of CAR-T therapy continues to evolve, Gilead’s latest achievement in reducing the manufacturing time of Yescarta stands out as a testament to the ongoing efforts to enhance cancer treatment and patient care. This development not only sets a new standard in the efficiency of delivering life-saving therapies but also underscores the importance of continual innovation in the fight against cancer.

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Related Services