Tag Archives: Yescarta

The EC Grants Yescarta Marketing Authorization for ≥4L R/R FL

On Tuesday, June 28, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Yescarta (CD19 CAR-T) in ≥4L r/r FL. Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Kymriah (Novartis’s CD19 CAR-T).

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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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Breyanzi Could Receive a CHMP Opinion for 2L LBCL (TI) as Early as September 2022; Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from June’s CHMP Highlights

On Friday, June 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in June’s CHMP Highlights. Below, the Celltelligence team provides a full analysis of June’s CHMP meeting with updated EU timelines for Breyanzi in 2L LBCL (TI) and Tecartus in r/r ALL.

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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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Breyanzi Starts EMA Assessment in 2L LBCL (TI); Tecartus and Yescarta Absent from June’s CHMP Agenda

On Monday, June 20, the CHMP agenda for June was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for 2L LBCL transplant-intended (TI) patients. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL and Yescarta (Gilead / Kite’s CD19 CAR-T) for 2L LBCL were absent from the CHMP agenda.

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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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Novartis Presents Updated Results for T-Charge Assets PHE885 and YTB323; A Comparative Analysis Demonstrates Kymriah’s Safety Superiority Over Yescarta in R/R FL; EHA 2022 Analysis 1

EHA 2022 Analysis 1: Novartis presented clinical updates for two T-Charge assets and a comparative study of Kymriah and Yescarta in r/r FL was reported. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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Initial Data from Yescarta’s Ph2 ZUMA-14 Study for R/R LBCL in Combination with Rituximab; Updated Results for Tecartus in ALL and MCL; ASCO 2022 Analysis 2

ASCO 2022 Analysis 2: Gilead (Kite) reported updated clinical data in LBCL, MCL, and adult B-ALL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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The Race Continues in the 2L LBCL Setting; BMS and Gilead Provide Clinical Updates for Breyanzi and Yescarta; ASCO 2022 Analysis 1

ASCO 2022 Analysis 1: Gilead (Kite) and BMS presented clinical data updates in 2L LBCL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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Yescarta in 2L LBCL and Tecartus in R/R ALL Absent from May’s CHMP Highlights

On Friday, May 20, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL and Tecartus (Gilead / Kite’s CD19 CAR-T) for r/r ALL were absent from May’s CHMP highlights. Below, the Celltelligence team provides updated EU timelines for Yescarta in 2L LBCL and Tecartus in r/r ALL.

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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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Could Yescarta in 2L LBCL Receive a CHMP Positive Opinion This Week?

On Monday, May 16, the CHMP agenda for May was released. Of note, Yescarta in 2L LBCL has been listed as for adoption under ‘Type II variations – variation of therapeutic indication’.

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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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Gilead’s Cell Therapy Sales Continue to Grow; Gilead’s New Manufacturing Facility Could Accelerate Yescarta’s Launch in 2L LBCL; Gilead’s Q1 2022 Earnings Call Summary

On Thursday, April 28, Gilead (Kite) held their Q1 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing new clinical developments for Yescarta (CD19 CAR-T). Additionally, management noted the FDA approval of their state-of-the-art manufacturing site in Frederick, MD. Below, Celltelligence provides insights on how Gilead’s new cell therapy facility could assist Yescarta’s expected increase in demand, while discussing Yescarta’s expansion into 2L LBCL.

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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Gilead’s Oncology Deep Dive 2022: Celltelligence Analysis – Part 2

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event (presentation) highlighting a rapid manufacturing process, while discussing strategies to remain innovative in the cell therapy space via robust collaborations and novel technologies. Below, Celltelligence provides a second round of insights on Gilead / Kite’s rapid manufacturing and off-the-shelf cell therapy candidates.

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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