Tag Archives: 2L LBCL

Caribou to Share FDA’s Feedback on Potential CB-010 Pivotal Trial by YE 2023; Caribou’s Q2 2023 Earnings Summary

On Tuesday, August 8, Caribou released their Q2 2023 results and business updates (press release) confirming plans to meet the FDA to discuss a potential pivotal trial for CB-010 (allogeneic CD19 CAR-T) in 2L LBCL and its hopes to share the FDA’s feedback by YE 2023. Moreover, the company highlighted the recent Pfizer investment in Caribou’s CB-011 (allogeneic BCMA CAR-T) program. Below, Celltelligence provides insights on how Caribou’s plans to run a potential trial in 2L LBCL may evolve and compares them to those of its main competitors.

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The EC Grants Breyanzi Marketing Authorization in 2L LBCL

On Wednesday, May 3, BMS announced (press release) that the European Commission (EC) has granted Breyanzi (CD19 CAR-T) approval for the treatment of ≥2L LBCL patients that have relapsed within 12 months or that are refractory to 1L chemoimmunotherapy. Below, Celltelligence provides insights on Breyanzi’s approval in the EU, while comparing it with its key competitor Yescarta (Gilead’s CD19 CAR-T).

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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 Breyanzi in 2L LBCL; When Could Abecma Receive a CHMP Positive Opinion for ≥3L MM? March CHMP Highlights

On Friday, March 31, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Breyanzi (BMS’s CD19 CAR-T) in 2L LBCL. Below, Celltelligence provides insights on the March CHMP meeting with updated EU timelines for Breyanzi’s approval and Abecma’s (BMS’s BCMA CAR-T) regulatory pathway to gain an indication in ≥3L MM.

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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 Absent from February’s CHMP Highlights

On Friday, February 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights implying that it has received a second RSI for its assessment in 2L LBCL. Below, Celltelligence provides updated EU approval timelines for Breyanzi.

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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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We’re Back! Holiday Recap Ahead of JPM 2023

It’s great to be back in 2023 serving our growing audience! Ahead of JPM Week, there were a few cell therapy-related news items:

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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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Updated Results from Breyanzi and Yescarta in 2L LBCL; ASH 2022 Analysis 3

ASH Analysis 3: BMS and Gilead presented clinical updates from their autologous CD19 CAR-Ts 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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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 Absent from November’s CHMP Agenda

On Monday, November 7, the CHMP agenda for November was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, November 11, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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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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Gilead Reports Increased Cell Therapy Revenue; Yescarta and Tecartus Approved in the EU; New Galapagos Asset Added to Gilead’s Pipeline; Viral Vector Manufacturing Plant Receives FDA Approval; Gilead’s Q3 2022 Earnings Call Summary

On Thursday, October 27, Gilead (Kite) held their Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing recent EC approvals for Yescarta and Tecartus (CD19 CAR-Ts). Moreover, Gilead included a new cell therapy asset in its pipeline and confirmed the FDA approval of its new vector manufacturing facility in Oceanside, CA. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how recently gained approvals in several geographies could increase the ex-US sales for Yescarta and Tecartus.

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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 EC Grants Yescarta Marketing Authorization in 2L LBCL

On Monday, October 17, Gilead (Kite) announced (press release) that the European Commission (EC) has granted Yescarta approval (CD19 CAR-T) for the treatment of DLBCL and high-grade B-cell lymphoma (HGBL) refractory patients or that have relapsed within 12 months of 1L chemoimmunotherapy (2L LBCL). Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Breyanzi (BMS’s CD19 CAR-T).

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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No Cell Therapy-Related Updates in August’s CHMP Agenda

On Tuesday, August 16, the CHMP agenda for August was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that for the CHMP meetings from June and July 2022, the Celltelligence team prepared two full analyses providing the following EC approval timelines for Breyanzi (BMS’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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