Tag Archives: Breyanzi

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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Abecma’s Revenue Increases +20% QoQ Driven by ex-US Sales; KarMMa-2 Results to be Presented at ASH 2022; NEX-T Programs Deprioritized; BMS Q3 2022 Earnings Call Summary

On Wednesday, October 26, BMS held its Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Additionally, management provided clinical updates for Abecma and noted the discontinuation of their NEX-T CAR-T programs. Below, Celltelligence provides insights on how Breyanzi and Abecma revenues compare with key competitors Kymriah (Novartis’s CD19 CAR-T), Yescarta (Gilead / Kite’s CD19 CAR-T), and Carvykti (JNJ / Legend’s BCMA CAR-T), while discussing the impact of BMS’s clinical updates in its strategy.

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

On Monday, October 10, the CHMP agenda for October was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that Breyanzi’s (BMS’s CD19 CAR-T) indication extension to 2L LBCL transplant-intended (TI) patients could potentially be included in November’s CHMP agenda (see previous insight).

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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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CHMP Adopts Positive Opinion for Yescarta; Breyanzi Absent from September’s CHMP Highlights

On Friday, September 16, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL. Additionally, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides insights on Yescarta’s positive opinion, while discussing updated EU timelines for Breyanzi.

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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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Type II Variations for Yescarta and Breyanzi Listed in September’s CHMP Agenda

On Monday, September 12, the CHMP agenda for September was released. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r DLBCL and high-grade B-cell lymphoma (HGBL), and 2L DLBCL Transplant Intended (TI) patients, respectively.

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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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UPDATED: Indications Table for BCMA and CD19 CAR-Ts US Approvals and Submissions

New content: The Celltelligence team has created a BCMA CAR-T indications table for estimated US approvals and submissions following key Q2 2022 earnings presentations and recent press releases (see below for download). Of note, no updates were observed in Celltelligence’s CD19 CAR-T indications table.

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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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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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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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Abecma’s Sales Increase While Breyanzi’s Revenue is Affected by Manufacturing Issues; No Clinical Milestone Updates for Breyanzi or Abecma; Oxford Biomedica’s Expanded LSA Agreement; BMS’s Q2 2022 Earnings Call Summary

On Wednesday, July 27, BMS held their Q2 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales decrease and US approval in 2L LBCL. Moreover, management reported a revenue increase for Abecma (BCMA CAR-T). Of note, no updated clinical milestones for Breyanzi and Abecma were observed. Below, Celltelligence provides insights on how Breyanzi and Abecma revenue compares with key competitors Kymriah (CD19 CAR-T; Novartis), Yescarta (CD19 CAR-T; Gilead / Kite), and Carvykti (BCMA CAR-T; JnJ / Legend). Additionally, Celltelligence discusses BMS’s LSA expansion agreement with Oxford Biomedica.

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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New Yescarta Ph2 Trial (ZUMA-24) for 2L LBCL in the Outpatient Setting Posted

On Friday, July 15, a new Kite-sponsored Ph2 trial (ZUMA-24) evaluating the outpatient administration of Yescarta (CD19 CAR-T) in 2L LBCL was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing how Yescarta’s outpatient treatment strategy compares with key competitor Breyanzi (BMS’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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on BMS (Blast 3/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1 and 2, Celltelligence discussed Novartis’s pipeline, novel cell types, manufacturing platform, and potential strategy in the solid tumor space (see previous insight part 1 here; see previous insight part 2 here). Below, Celltelligence provides its analysis on BMS’s pipeline, novel cell types, platforms, and solid tumor strategy. In subsequent blasts, Celltelligence will provide a similar overview for Gilead (Kite). At the end of the series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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