Tag Archives: Abecma

Will Abecma Receive a Positive CHMP Opinion by June 24? Breyanzi’s EU Regulatory Delay Continues; CAT Agenda June 2021

On Wednesday, June 16, the Committee for Advanced Therapies’s (CAT) agenda (June 16 – 18) was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed as ‘for opinion’ in June’s CAT agenda, while BMS has requested a clock-stop extension for Breyanzi (BMS; CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and 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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Cilta-cel Continues to Demonstrate Best-in-Class Efficacy With an Improved Safety Profile; Abecma’s Efficacy in Hard-to-Treat Subgroups; Could Gracell’s FasTCAR GC012F (BCMA x CD19) Further Decrease TATs? Thoughts on Arcellx’s Initial Results From CART-ddBCMA; ASCO 2021 Day 4

On the final day of ASCO 2021, eight key clinical updates were presented from JNJ / Legend, BMS, Gracell, and Arcellx. 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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Canada Approves BMS’s Abecma (BCMA CAR-T) in ≥4L R/R MM; Will the Earliest Reimbursement Occur in 2022?

On Monday, May 31, BMS announced (press release) that Health Canada has granted conditional approval for Abecma (BCMA CAR-T) in ≥4L r/r MM, based on results from the Ph2 KarMMa trial. Below, Celltelligence provides insights on Abecma’s conditional approval in an earlier line of therapy compared to the US, while discussing when an earliest possible decision on reimbursement in Canada could occur.

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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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JNJ / Legend Receive Priority Review for Cilta-cel in MM; Approval Before Thanksgiving?

On Wednesday, May 26, Legend announced (press release) that the FDA has granted cilta-cel (BCMA CAR-T) Priority Review in r/r MM, with a projected PDUFA date around November 29, 2021. Furthermore, management confirmed that updated results from the Ph1b/2 CARTITUDE-1 trial will be presented at ASCO 2021. Below, Celltelligence provides additional thoughts on cilta-cel’s anticipated US approval and its potential best-in-class efficacy profile, while discussing JNJ’s / Legend’s possible US ATC onboarding strategy.

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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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No Mention of Abecma, Breyanzi, or Cilta-cel in May’s CHMP Agenda

On Monday, May 17, the CHMP agenda for May was released. Of note, no major updates were observed for Abecma (BMS), Breyanzi (BMS), or cilta-cel (JNJ / Legend). Below, Celltelligence provides an update on likely EU approval timelines for Abecma, Breyanzi, and 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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Allogene Doses First Patients With ALLO-316 (CD70 CAR-T) and Presents Novel TurboCARs for Solid Tumors; bluebird’s Oncology Newco Renamed as 2seventy bio; Allogene and bluebird bio Q1 2021 Earnings Call Summaries

On Wednesday, May 5, Allogene held their Q1 2021 earnings call (press release) highlighting the initiation of ALLO-316’s Ph1 TRAVERSE trial in renal cell carcinoma (RCC) and provided several updates across their CAR-T programs. On the same day, bluebird bio reported their Q1 2021 results (press release) and confirmed that the oncology Newco will be called 2seventy while highlighting Abecma’s FDA approval in ≥5L MM. Below, Celltelligence provides insights on how Allogene may strategically advance their CAR-T programs while discussing Allogene’s growing potential in the solid tumor setting with their TurboCAR platform. Furthermore, Celltelligence will discuss 2seventy bio’s corporate structure while commenting on Abecma’s potential EU approval timeline.

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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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BMY: Q1 2021 Earnings Call Summary

On Thursday, April 29, BMS held their Q1 2021 earnings call (press release / presentation), highlighting the rapid onboarding of ATCs for Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T) in the US. Below, Celltelligence provides insights on how BMS may leverage Breyanzi and Abecma onboarding as a package for centers hesitant to offer a third 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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First BCMA CAR-T Approved in the US for Multiple Myeloma; Will Abecma’s 33-day TAT and High Price Prevent Wide-Spread Adoption?

On Friday, March 26, BMS and bluebird bio announced (press release) that the FDA approved Abecma (idecabtagene vicleucel) for the treatment of ≥5L r/r MM (i.e. after completing at least 4 lines of prior therapy). Below, Celltelligence provides thoughts on Abecma’s higher list price and longer TAT vs. approved CD19 CAR-Ts, while discussing Abecma’s potential messaging strategy.

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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