Tag Archives: BMS

Abecma Approved in Japan; Can BMS Meet the Increased Manufacturing Demand? Novartis and Pack Health Explore Digital Coaching to Improve Quality of Life Outcomes Following CAR-T Treatment

On Thursday, January 20, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Abecma (BCMA CAR-T) for the treatment of ≥4L r/r MM. Moreover, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with Novartis and Ohio State University Comprehensive Cancer Center appearing as collaborators. Below, Celltelligence provides insights on Abecma’s potential market access in Japan, while commenting on how the current viral vector shortage could limit BMS’s ability to deliver Abecma in Japan.

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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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Allogene’s FDA Clinical Hold Lifted; JPM 2022 Day 1: BMS, Novartis, JNJ, and Gilead

On Monday, January 10, Allogene (press release) announced that the FDA has lifted the clinical hold on their AlloCAR-T programs. Moreover, on the first day of JPM 2022, Celltelligence covered presentations by BMS (press release / presentation), Novartis (presentation), JNJ (press release), and Gilead (presentation). 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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Kymriah Absent From December’s CHMP Highlights

On Friday, December 17, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, no updates from Kymriah’s Type II variation in r/r FL were observed. Below, Celltelligence provides updated likely EU approval timelines for Kymriah, Yescarta, Tecartus, Breyanzi, and Carvykti (cilta-cel).

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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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Will Kymriah Receive a CHMP Positive Opinion in R/R FL This Week? Carvykti’s CHMP Opinion Likely to Occur by February 2022; Tecartus and Breyanzi Continue to Experience Delays; December’s CHMP Agenda

On Monday, December 13, the CHMP agenda for December was released. Of note, Kymriah’s (Novartis’s CD19 CAR-T) Type II variation for r/r FL is listed as ‘For Adoption’, while Carvykti (JNJ / Legend’s BCMA CAR-T; cilta-cel) is displayed under the ‘List of outstanding issues (LoOI)’ section. Moreover, Tecartus (Gilead’s / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) were absent from December’s CHMP agenda. Below, Celltelligence provides insights on potential EU approval timelines for Kymriah and Carvykti, while discussing possible causes for Tecartus’s and Breyanzi’s regulatory delays.

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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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Will a KarMMa Data Cut Help Abecma’s Successor Products? Safety and Efficacy Updates From bb21217’s Ph1 CRB-402 Study; Carvykti’s CARTITUDE-1 Continues Demonstrating Positive Clinical Results; ASH 2021 Day 2 Part 1

On the second day of ASH 2021, 3 clinical updates were presented by BMS, 2seventy, and Legend. Below, Celltelligence provides insights and context for each presentation.

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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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The Race to 2L DLBCL: Breyanzi’s Ph3 TRANSFORM Trial vs Yescarta’s Ph3 ZUMA-7 Study; Can BMS Shift Toward Outpatient CD19 CAR-T Administration? ASH 2021 Day 1 Part 2

On the first and second day of ASH 2021, 4 clinical updates were presented by BMS and Gilead (Kite) including Breyanzi’s (CD19 CAR-T) and Yescarta’s (CD19 CAR-T) efficacy and safety profiles in 2L DLBCL. Moreover, BMS commented on the feasibility of administering Breyanzi in the outpatient setting. Below, Celltelligence provides insights and context for each presentation.

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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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Will Abecma Receive Approval in Japan by January 2022? Could JNJ / Legend’s Carvykti be Approved by September 2022?

On Monday, December 6, Japan’s Pharmaceutical Affairs and Food Sanitation Council (PAFSC) granted Abecma (BMS’s BCMA CAR-T) a positive opinion (press release, PharmaJapan, Dec 2021). Below, Celltelligence provides insights on Abecma’s potential approval and reimbursement timeline in Japan.

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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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JNJ / Legend Files Carvykti in Japan for R/R MM

On Monday, December 6, Legend announced (press release) that they have submitted Carvykti’s NDA (cilta-cel; BCMA CAR-T) to Japan’s Ministry of Health Labour and Welfare (MHLW) for the treatment of r/r MM. Below, Celltelligence provides insights on a likely approval timeline for Carvkyti in Japan.

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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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NICE Suspends Breyanzi’s Appraisal for R/R NHL

On Tuesday, November 9, NICE reported that Breyanzi’s (BMS’s CD19 CAR-T) clinical and cost-effectiveness appraisal was ‘suspended’ (website). Below, Celltelligence provides insights on the importance and potential causes for Breyanzi’s suspended appraisal in the UK.

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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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New Yescarta Study in R/R DLBCL for Outpatient Administration

On Friday, November 5, a new investigator-initiated study evaluating Gilead (Kite)’s Yescarta (CD19 CAR-T) in the outpatient setting for r/r DLBCL was observed on CT.gov. Below, Celltelligence provides details for this trial, while discussing how this Yescarta outpatient study compares to 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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