Tag Archives: Breyanzi

No Cell Therapy Updates in October’s CHMP Highlights

On Friday, October 15, 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 October’s CHMP Highlights. Recall that on Wednesday, October 13, 2021, the Celltelligence team prepared a full analysis on October’s CHMP agenda, discussing Breyanzi’s continued regulatory delay and in-depth scenarios for EC approvals of the following cell therapy products (see previous insight):

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Thoughts on Breyanzi’s Continuing EU Regulatory Delays; Will Kymriah Receive a Positive CHMP Opinion for R/R FL in December 2021? No Updates for Tecartus, Cilta-cel, and Yescarta in October’s CHMP Agenda

On Monday, October 11, the CHMP agenda for October was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘List of outstanding issues (LoOI)’ section, while Kymriah (Novartis’s CD19 CAR-T) has been listed under ‘Type II variations’ to include ≥3L r/r FL as a new indication. No updates were observed for Tecartus (Gilead’s CD19 CAR-T), cilta-cel (JNJ / Legend’s BCMA CAR-T), or Yescarta (Gilead’s CD19 CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi and Kymriah.

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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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Gilead Files an sBLA for Yescarta in 2L R/R DLBCL

On Thursday, September 30, Gilead (Kite) announced (press release) that they have submitted an sBLA to the FDA for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Of note, Yescarta’s sBLA application is supported by data from the Ph3 ZUMA-7 trial in 2L r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s estimated FDA approval timeline for 2L r/r DLBCL, while discussing how Breyanzi (BMS) and Kymriah (Novartis) compare in the 2L setting.

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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 Tecartus Receive a Positive CHMP Opinion for R/R Adult ALL This Week? Cilta-cel Remains on Track for a November 2021 Opinion; No Mention of Breyanzi or Yescarta in September’s CHMP Agenda

On Monday, September 13, the CHMP agenda for September was released. Of note, Tecartus’s (Gilead’s CD19 CAR-T) Type II Variation for r/r adult ALL is listed as ‘For Adoption’, while cilta-cel (JNJ / Legend’s BCMA CAR-T) appears under the ‘List of Questions (LoQ)’ section. No updates were observed for Breyanzi (BMS’s CD19 CAR-T) in DLBCL or Yescarta (Gilead’s CD19 CAR-T) in FL. Below, Celltelligence provides likely EU approval timelines for Tecartus 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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Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, and cilta-cel.

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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’s Viral Vector Shortage; Could JNJ Take Advantage? BMS Q2 2021 Earnings Call Summary

On Wednesday, July 28, BMS held their Q2 2021 earnings call (press release / presentation), highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) strong demand following their recent US approval, while discussing Abecma’s manufacturing bottleneck due to a shortage of viral vector. On the same day, bluebird bio announced (press release) a strategic alliance with Resilience for the sale of bluebird’s lentiviral manufacturing facility in North Carolina. Below, Celltelligence provides insights on how Abecma’s upcoming approval in the EU could impact BMS’s viral vector shortage and if JNJ could take advantage for cilta-cel’s launch.

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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 a Positive CHMP Opinion on June 24? BMS Seeks a Clock-Stop Extension for Breyanzi; CHMP Agenda June 2021

On Monday, June 21, the CHMP agenda for June was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed under the Opinions section, while the CHMP appears to require further information in relation to BMS’s clock-stop extension request for Breyanzi (BMS’s CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and Breyanzi.

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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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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

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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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Yescarta Outperforms SoC in a Matched Analysis of ZUMA-5 in r/r FL; Tecartus’s Improved Safety Profile in the Ph1/2 ZUMA-4 Trial; Breyanzi’s Ph2 OUTREACH Trial Demonstrates the Feasibility of Outpatient Administration; Obe-cel Reports a Possible Best-in-Class Profile for Adult ALL; Mustang Bio’s MB-106 Reports a 93% ORR in NHL; EHA 2021 Day 3

On the last day of EHA 2021, five key clinical updates were presented from Gilead (Kite), BMS, Autolus, and Mustang Bio. Below, Celltelligence provides insights and context for each presentation.

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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 Reports Positive Topline Results From Breyanzi’s Ph3 TRANSFORM Trial in 2L DLBCL vs SoC: Will Breyanzi be the First Approved CAR-T in 2L DLBCL?

On Thursday, June 10, BMS reported positive topline results from Breyanzi’s (CD19 CAR-T) Ph3 TRANSFORM trial in 2L DLBCL (press release). Below, Celltelligence provides insights on how Breyanzi’s potential approval timeline in 2L DLBCL compares with key competitors Kymriah (Novartis) and Yescarta (Gilead / Kite).

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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