Tag Archives: BMS

Carvykti and Abecma Receive FDA Approval for Early Lines of MM

On Friday, April 5, JNJ (press release) and Legend (press release) announced that the FDA approved Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

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You May Have Missed: New Breyanzi Ph3 Trial for R/R FL; Abecma Approved for 3L MM in the EU

In the past week, the Celltelligence team detected relevant news that was not discussed in individual blasts but worth highlighting. In this blast, Celltelligence will cover the following topics:

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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 the FDA ODAC Recommending Carvykti and Abecma in Earlier Lines of MM

On Friday, March 15, JNJ (press release) and Legend (press release) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide.

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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 Receives FDA Accelerated Approval in ≥3L CLL/SLL

On Thursday, March 14, BMS announced (press release) that the FDA granted accelerated approval (AA) of Breyanzi (CD19 CAR-T) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) adult patients who have received at least 2 prior LoT including a BTK inhibitor and a BCL-2 inhibitor.

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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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New BMS-986393 Ph2 Trial (QUINTESSENTIAL) for R/R Multiple Myeloma

On Thursday, March 7, a new BMS-sponsored Ph2 trial (QUINTESSENTIAL) evaluating BMS-986393 (CC-95266; GPRC5D CAR-T) in quadruple-class exposed [including: an immune modulatory drug (IMiD), a proteasome inhibitor (PI), an anti-CD38 mAb, and an anti-BCMA therapy] ≥4L MM was observed on CT.gov.

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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 and Breyanzi Revenues Increase; BMS-986353 to be Evaluated in MS; BMS’s Q4 2023 Earnings Call Summary

On Friday, February 2, BMS held its Q4 2023 earnings call (press release / presentation) highlighting the increase in global sales of Abecma (BMS / 2seventy bio’s BCMA CAR-T) and Breyanzi (CD19 CAR-T) while reporting plans to evaluate its BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in multiple sclerosis (MS).

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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 Regulatory Applications for R/R FL and R/R MCL Accepted in the US and Japan

On Tuesday, January 30, BMS announced (press release) that the Breyanzi (CD19 CAR-T) sBLAs for r/r FL and r/r MCL have been accepted by the FDA with projected PDUFA dates on May 23, 2024, and May 31, 2024, respectively. Additionally, the application for Breyanzi in r/r FL has also been validated in Japan.

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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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CHMP Adopts Positive Opinion for Abecma in ≥3L MM; January CHMP Highlights

On Friday, January 26, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Abecma (BMS’s BCMA CAR-T) in ≥3L MM.

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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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Could Abecma Receive a CHMP Positive Opinion on Friday?; January’s CHMP Agenda

On Monday, January 22, the CHMP agenda for January was released including Abecma (BMS / 2seventy bio’s BCMA CAR-T) in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while the Carvykti (JNJ / Legend’s BCMA CAR-T) Type II Variation for ≥2L MM was absent from the agenda.

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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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JPM 2024 Analysis Day 1: BMS, Gilead, Novartis, and JNJ

On the first day of JPM 2024, Celltelligence covered presentations by BMS (presentation / webcast), Gilead (presentation / webcast), Novartis (presentation / webcast), and JNJ (webcast). 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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