On Friday, July 24, Gilead announced (press release) FDA accelerated approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only CAR-T treatment for r/r mantle cell lymphoma (MCL). Priority review for Tecartus was based on results from the Ph2 ZUMA-2 trial; a single-arm, open-label study in which 87% of patients responded, with a 62% CR rate. Below, Celltelligence provides manufacturing insights between Yescarta/Tecartus, and how Gilead’s onboarding policy may influence competitors’ future roll-out of additional CAR-T products.
About The Author
The Celltelligence Team
Content Leads & Contributors
The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.
If you receive our email blasts, you already have an account. Log in now
Sign UpFREE
You’ll be able to access the full article from your Celltelligence Library after signing up.
If you receive our email blasts, you already have an account. Log in now
Context counts when making decisions.
Sign UpFREE
You’ll be able to access the full article from your Celltelligence Library after signing up.