Tag Archives: Tecartus

The EC Grants Tecartus Conditional Marketing Authorization for r/r MCL; UPDATED: US CAR-T Approvals Table

New content: The Celltelligence team has included and updated its CAR-T indications table for estimated approvals and submissions in the US (see below for download). 

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The Celltelligence Team

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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.

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CHMP Adopts Positive Opinion for Gilead’s Tecartus in r/r Mantle Cell Lymphoma

On Friday, October 16, Gilead announced (press release) that the CHMP has adopted a positive opinion for Tecartus (brexucabtagene autoleucel, formerly KTE-X19) in ≥3L r/r mantle cell lymphoma (MCL). If approved by the EC, Tecartus would become the first and only CAR-T treatment approved for r/r MCL in Europe. Below, Celltelligence provides thoughts on Tecartus’s positive CHMP opinion and the likelihood of Gilead onboarding EU centers within 30 days of EC approval.

About The Author

The Celltelligence Team

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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.

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Thoughts on Gilead’s Recent FDA Approval for Tecartus (KTE-X19) in R/R Mantle Cell Lymphoma

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

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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.

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