Tag Archives: BMS

Thoughts on Breyanzi’s FDA Approval in 2L LBCL

On Friday, June 24, BMS announced (press release) that the FDA approved Breyanzi (CD19 CAR-T) in 2L LBCL. Of note, Breyanzi’s approval in 2L LBCL is based on results from the Ph3 TRANSFORM study and Ph2 PILOT trial. Below, Celltelligence provides insights on how Breyanzi’s broad label in 2L LBCL compares with key competitor Yescarta (Gilead / Kite’s CD19 CAR-T), while discussing how BMS may position Breyanzi in the 2L setting.

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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 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

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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 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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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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Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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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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Fate’s Novel FT573 Pan-Tumor Targeting Asset and Tri-Modal CAR-TCR Platform; Shoreline’s iPSC-derived Screening Platform; BMS’s Abecma to be Reimbursed in Japan on April 20; AACR 2022 Final Analysis

AACR 2022 Final Analysis: Several preclinical results were presented from Fate Tx, and Shoreline. Additionally, a cell therapy-related piece of news was observed, with Abecma set to become reimbursed in Japan after joining the NHI’s reimbursement price list on April 20, 2022. Below, Celltelligence provides insights and context for each presentation. 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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Thoughts on Breyanzi’s sNDA Acceptance in Japan for 2L LBCL

BMS recently announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) accepted Breyanzi’s (CD19 CAR-T) sNDA in 2L LBCL. Below, Celltelligence provides insights on Breyanzi’s potential approval timeline for 2L LBCL in Japan, while discussing possible reimbursement issues as the CD19 CAR-T moves into earlier lines of therapy.

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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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BMS Receives Priority Review for Breyanzi in 2L LBCL; Breyanzi’s PDUFA Date Set for June 24, 2022

On Thursday, February 17, BMS announced (press release) that the FDA has granted a Priority Review for Breyanzi (CD19 CAR-T) in 2L LBCL, with a PDUFA date of June 24, 2022. Below, Celltelligence provides additional thoughts on how Breyanzi’s anticipated US approval in the 2L setting compares with Yescarta (Gilead / Kite; 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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Breyanzi’s Sales Increase While Abecma’s Remain Flat; How Will BMS Meet CAR-T Manufacturing Demand? Breyanzi On Track for EU Approval in 2L LBCL; BMS’s Q4 2021 Earnings Call Summary

On Friday, February 4, BMS held their Q4 2021 earnings call (press release / presentation) highlighting their manufacturing supply strategy for the anticipated increase in demand of Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T). Below, Celltelligence provides insights on the potential challenges BMS may encounter expanding into earlier lines of therapy and additional geographies.

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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 BMS’s Breyanzi in ≥3L R/R DLBCL

On Friday, January 28, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted (press release) a positive opinion for Breyanzi’s (liso-cel; BMS’s CD19 CAR-T) marketing authorization in ≥3L r/r DLBCL, PMBCL, and FL grade 3B. Below, Celltelligence provides thoughts on Breyanzi’s positive CHMP opinion, while comparing Breyanzi’s regulatory EU timeline with other commercialized CAR-Ts.

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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