Tag Archives: 2L LBCL

Breyanzi Receives FDA Approval for 2L LBCL

Late on Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL based on results from the Ph3 TRANSFORM trial and Ph2 PILOT study. Of note, Breyanzi is the second CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days.

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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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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:

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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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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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Breyanzi’s Sales Increase While Abecma’s Remain Flat; BMS Prepares for an Increase in Cell Therapy Demand; No Clinical Milestone Updates for Breyanzi or Abecma; BMS’s Q1 2022 Earnings Call Summary

On Friday, April 29, BMS held their Q1 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) revenue increase and anticipated US approval in 2L LBCL. Of note, no updated clinical milestones for Breyanzi and Abecma (BCMA CAR-T) were observed. Below, Celltelligence provides insights on how Breyanzi’s revenue increase compares with Kymriah (Novartis’s CD19 CAR-T) and Yescarta (Gilead/Kite’s CD19 CAR-T).

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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.

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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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