Yescarta Outperforms Long-Standing Standard in R/R LBCL, Gilead Celebrates Greater Overall Survival!

Tuesday marked a major milestone for Gilead’s Kite Pharma, as their Yescarta treatment became the first in nearly three decades to show an improvement in overall survival for those suffering from relapsed/refractory large B-cell lymphoma. This breakthrough in medical research is sure to bring hope to countless patients around the world.

Patients with a certain type of blood cancer may now have a longer life expectancy, thanks to the promising results of a recent clinical trial, the Zuma-7 study. This study showed that patients who received the CD19-directed CAR-T cell therapy lived longer than those who stuck to the current standard of care, a multistep regimen that has been in use for nearly three decades.

Kite’s groundbreaking research showed that, compared to the control group, patients receiving Yescarta experienced a significant improvement in overall survival. In fact, they were 2.5 times more likely to be alive and disease-free two years from treatment.

This impressive outcome speaks to the life-saving potential of Yescarta, underscoring its importance for those in need of a potentially lifesaving therapy.

Zuma-7 underwent a rigorous Special Protocol Assessment with the FDA, in which both parties agreed on the trial design, clinical endpoints and statistical analysis for the study before it began. This process ensured that the trial was conducted in a safe, efficient and effective manner.

The analysis was met with widespread approval, with other regulatory authorities also giving their full support. Kite reported that the response to the analysis had been overwhelmingly positive.

Kite Pharma’s Zuma-7 pivotal trial achieved success in its primary endpoint of event-free survival, showing superiority to the standard of care. This data was instrumental in the FDA granting approval for Yescarta’s use in the initial treatment of relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in April 2022, followed by European Union (EU) approval the following October.

Yescarta has been approved for the treatment of RR LBCL in four countries across the globe – Great Britain, Israel, Japan and Switzerland. This revolutionary treatment offers a new hope for those affected by this condition, providing an opportunity for improved quality of life.

Kite is gearing up to showcase comprehensive data from the groundbreaking Zuma-7 mission at an upcoming scientific gathering, offering the audience an exciting glimpse into a new era of exploration.

Yescarta, a CAR-T cell therapy, is going head-to-head with Bristol Myers Squibb’s Breyanzi, which was recently approved by the FDA in June 2022 for the second-line treatment of R/R LBCL. This marks the start of a fierce competition between the two treatments, with each one vying for the attention of patients and healthcare providers.

In 2017, Gilead’s Yescarta launched with resounding success, contributing $337 million to the company’s fourth quarter sales in 2022. This increase in revenue is attributed to its popularity as a R/R LBCL therapy in the U.S. and EU. Similarly, Breyanzi, approved in 2021, has proven to be a lucrative asset for BMS, bringing in a total of $182 million in 2022.

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