Tag Archives: JNJ

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 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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Is Competition from Breyanzi Responsible for a Decline in Kymriah’s Sales? Cilta-cel Remains on Track to Gain FDA Approval by EOY; Novartis and JNJ Q2 2021 Earnings Call Summaries

On Wednesday, July 21, Novartis held their Q2 2021 earnings presentation (press release / presentation) highlighting Kymriah’s sales decline. Of note, no major clinical or regulatory updates were reported. On the same day, JNJ presented their Q2 2021 financial results (press release  / presentation) highlighting the submission of cilta-cel’s (BCMA CAR-T) MAA to the EMA. Below, Celltelligence provides insights on how Breyanzi’s approval in the US could have negatively impacted Kymriah’s Q2 2021 sales while discussing cilta-cel’s potential US and EU regulatory timelines.

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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 Announce a New EU Manufacturing Site in Belgium

On Tuesday, June 22, JNJ (press release) and Legend (press release / presentation) announced the establishment of a state-of-the-art manufacturing facility in Ghent, Belgium. Of note, the new manufacturing site could become a key pillar for JNJ / Legend’s global collaboration to develop and commercialize cilta-cel (BCMA CAR-T). Below, Celltelligence provides insights into JNJ / Legend’s potential manufacturing strategy in Europe and how this compares to key competitor BMS.

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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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Cilta-cel Demonstrates Improved Efficacy in Matched Analyses vs SoC; Cilta-cel’s New CARTITUDE-5 Trial in NDMM; Anakinra Prophylaxis Fails to Improve Orva-cel’s Safety Profile; Initial Clinical Data from Celyad’s CYAD-211 BCMA CAR-T; Gracell’s Investor Event: Will MRD Negativity Become a New Surrogate Marker? Updated Clinical Data from IASO’s CT103A; EHA 2021 Day 2

On the second day of EHA 2021, six key clinical updates were presented from JNJ / Legend, BMS, Celyad, Gracell, and IASO Biotherapeutics. Of note, Celyad and Gracell held two EHA-related investor events, while a new clinical trial for cilta-cel was observed on CT.gov. 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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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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Cilta-cel’s Submission on Track in the US, Europe, China, and Japan; Multiple Cilta-cel Clinical Updates Expected at ASCO and EHA 2021; Legend Q1 2021 Earnings Summary

On Tuesday, May 18, Legend released their Q1 2021 financial results (press release), highlighting that cilta-cel’s (BCMA CAR-T) US and EU regulatory approvals in r/r MM remain on track, with submissions in China and Japan anticipated in H2 2021. Furthermore, management confirmed that a number of cilta-cel clinical updates will be presented at ASCO and EHA 2021. Below, Celltelligence provides updated timelines for cilta-cel’s approval in the US and EU, while detailing cilta-cel’s upcoming clinical updates.

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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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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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GILD: Q1 2021 Earnings Call Summary; JNJ: Cilta-cel MAA Submitted

On Thursday, April 29, Gilead held their Q1 2021 earnings call (press release / presentation), highlighting the rapid recovery of their cell therapy sales revenue, while discontinuing several Yescarta and Tecartus programs. Furthermore, on Friday, April 30, JNJ announced (press release) cilta-cel’s (BCMA CAR-T) MAA submission to the EMA for r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s European expansion to recover and grow market share, while discussing cilta-cel’s potential EU approval timelines.

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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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Humanigen Cancels Collaboration with Gilead (Kite) to Test Lenzilumab with Other Commercial CD19 CAR-Ts; FDA Accepts Allogene’s TurboCAR ALLO-605 (BCMA CAR-T) IND; First Patient Dosed with Ziopharm’s RPM CD19 CAR-T in Taiwan; No Regulatory Updates for Cilta-cel in JNJ’s Q1 2021 Earnings Call

A series of cell therapy-related news items have been observed:

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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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Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

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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