Tag Archives: BMS

Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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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Uncertainty around OS Benefit Induced by Abecma in 3 – 5L MM; A MAIC Analysis Supports Carvykti’s Superiority versus Abecma in Early Line MM; ASH 2023 Analysis 7

ASH 2023 Analysis 7: BMS / 2seventy and JNJ / Legend presented analyses from their BCMA CAR-Ts in early line MM. 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 Demonstrates Excellent Efficacy in 2L HR FL; Galapagos’s Point-of-Care Manufactured GLPG5101 Shows a Promising Efficacy and Safety Profile; ASH 2023 Analysis 4

ASH 2023 Analysis 4: BMS and Galapagos presented updated clinical data about their cell therapies in lymphoma. 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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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 Demonstrates Long Duration of Response in 2L Transplant Ineligible LBCL and Consistent RW Results Regardless of Comorbidities in R/R LBCL; Prior Bridging Therapy Does Not Impact Yescarta Efficacy or Safety in R/R LBCL; ASH 2023 Analysis 3

ASH 2023 Analysis 3: Gilead (Kite) and BMS presented real-world (RW) and clinical data updates in r/r 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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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-986393 Continues Showing Impressive ORR in ≥4L MM but Durability Fails to Impress; Initial Promising Results from AUTO8 in r/r MM; ASH 2023 Analysis 1

ASH 2023 Analysis 1: BMS and Autolus presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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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Abecma sBLA to Face FDA AdCom; PDUFA Date Delayed; Could Carvykti Be Approved Before Abecma in Earlier Lines of MM?

On Monday, November 20, BMS / 2seventy bio announced (press release) that the FDA Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the sBLA for Abecma (BCMA CAR-T) in triple-class exposed MM. Importantly, the companies disclosed the FDA will not meet the PDUFA date originally set for December 16, 2023. Below, Celltelligence provides insights on the possible reasons behind the FDA’s decision, while discussing potential timelines for the ODAC meeting and the new PDUFA date.

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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 Revenue Decreases Significantly; bbT4015 IND on Track for YE 2023; JW Tx to Initiate JWTCR001’s IIT by YE 2023; 2seventy Bio’s Q3 2023 Earnings Call

On Tuesday, November 14, 2seventy bio held its Q3 2023 earnings call (press release / webcast) acknowledging Abecma’s (BMS / 2seventy’s BCMA CAR-T) decline in US sales while confirming milestones for its preclinical cell therapy programs in solid tumors. Below, Celltelligence provides insights on the causes behind Abecma’s revenue decrease while discussing the company’s preclinical solid tumor pipeline.

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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 sBLA for R/R CLL/SLL Receives FDA Priority Review

On Thursday, November 9, BMS announced (press release) FDA accepted the sBLA for the expansion of Breyanzi’s (CD19 CAR-T) label to include r/r chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The company confirmed that the FDA has granted Priority Review to the application and set a PDUFA date of March 14, 2024. Below, Celltelligence provides insights on the results of the Ph1/2 TRANSCEND CLL 004 trial supporting the application while discussing BMS’s strategy for the hypothetical use of Breyanzi in 2L CLL/SLL.

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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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Abecma T2V Receives a Second RSI; When Could Abecma and Carvykti Receive a Positive CHMP Opinion? November CHMP Highlights

On Friday, November 10, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights, implying that it has received a second Request for Supplementary Information (RSI) for its approval in ≥3L MM. Moreover, recall that the Carvykti (JNJ’s / Legend’s BCMA CAR-T) T2V in ≥2L MM was not included on Monday’s CHMP Agenda. Below, Celltelligence provides insights on the November CHMP meeting with updated EU timelines for both cell therapies.

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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BMS’s Cell Therapy Franchise Sales Decrease; KarMMa-9 Initiated; The FDA Clears BMS-986353’s IND in MS; First Patients in SLE Trial Dosed; BMS’s Q3 2023 Earnings Call Summary

On Thursday, October 26, BMS held its Q3 2023 earnings call (press release / presentation) disclosing a significant revenue decrease for Abecma (BCMA CAR-T) and a decline in Breyanzi (CD19 CAR-T) sales. Additionally, BMS confirmed the dosing of the first patient in the Ph1 trial evaluating BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in severe refractory systemic lupus erythematosus (SLE), while announcing IND clearance from the FDA to start a trial in multiple sclerosis (MS). Below, Celltelligence provides insights on the potential causes behind the Abecma and Breyanzi sales drops while discussing the initiation of the Ph3 KarMMa-9 trial in NDMM and BMS’s fast progress in the autoimmune disease space.

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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