Tag Archives: Yescarta

Could Breyanzi Receive a Positive CHMP Opinion This Week? Tecartus Continues to Experience Delays; January’s CHMP Agenda

On Monday, January 24, the CHMP agenda for January was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘Opinions’ section. No other key cell therapy-related updates were observed. Below, Celltelligence provides insights on the potential EU approval timeline for Breyanzi, while discussing regulatory timelines for Kymriah and Yescarta in r/r FL, Tecartus in r/r adult ALL, and Carvykti in r/r MM.

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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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Kymriah Absent From December’s CHMP Highlights

On Friday, December 17, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, no updates from Kymriah’s Type II variation in r/r FL were observed. Below, Celltelligence provides updated likely EU approval timelines for Kymriah, Yescarta, Tecartus, Breyanzi, and Carvykti (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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Daiichi Sankyo Authorizes Yescarta’s First Treatment Center in Japan 11 Months After Approval

On Thursday, December 16, Gilead (Kite) announced (press release) that Daiichi Sankyo has authorized Yescarta’s (Gilead’s CD19 CAR-T) first treatment center in Japan. Below, Celltelligence provides insights on how Yescarta’s footprint in Japan may potentially increase Gilead’s (Kite) WW market revenue, while discussing differences in ATC onboarding rates between the US and 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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Novartis May Apply Learnings from BELINDA’s Failure to YTB323 in 2L DLBCL; How Could Novartis Position Their Novel T-Charge Manufacturing Platform in 2L DLBCL and MM Settings? Yescarta’s ZUMA-12 Demonstrates an 89% ORR in 1L DLBCL; ASH 2021 Day 3

On the last day of ASH 2021, 6 clinical updates were presented by Novartis and Gilead (Kite). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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 Kymriah Receive a CHMP Positive Opinion in R/R FL This Week? Carvykti’s CHMP Opinion Likely to Occur by February 2022; Tecartus and Breyanzi Continue to Experience Delays; December’s CHMP Agenda

On Monday, December 13, the CHMP agenda for December was released. Of note, Kymriah’s (Novartis’s CD19 CAR-T) Type II variation for r/r FL is listed as ‘For Adoption’, while Carvykti (JNJ / Legend’s BCMA CAR-T; cilta-cel) is displayed under the ‘List of outstanding issues (LoOI)’ section. Moreover, Tecartus (Gilead’s / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) were absent from December’s CHMP agenda. Below, Celltelligence provides insights on potential EU approval timelines for Kymriah and Carvykti, while discussing possible causes for Tecartus’s and Breyanzi’s regulatory delays.

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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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The Race to 2L DLBCL: Breyanzi’s Ph3 TRANSFORM Trial vs Yescarta’s Ph3 ZUMA-7 Study; Can BMS Shift Toward Outpatient CD19 CAR-T Administration? ASH 2021 Day 1 Part 2

On the first and second day of ASH 2021, 4 clinical updates were presented by BMS and Gilead (Kite) including Breyanzi’s (CD19 CAR-T) and Yescarta’s (CD19 CAR-T) efficacy and safety profiles in 2L DLBCL. Moreover, BMS commented on the feasibility of administering Breyanzi in the outpatient setting. 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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Could Autolus’s AUTO1/22 Novel CD22 Binder Avoid Antigen-Related Relapse in ALL? Updated Results from Cellectis’s UCART22 Ph1 BALLI-01 Trial; Yescarta’s Ph2 ZUMA-5 Trial Continues to Demonstrate Positive Long-Term Results; ASH 2021 Day 1 Part 1

On the first day of ASH 2021, 3 clinical updates were presented by Autolus, Cellectis, and Gilead. Below, Celltelligence provides insights and context for each presentation. In a subsequent blast, the Celltelligence team will provide insights from Precision’s PBCAR0191 (allogeneic CD19 CAR-T) clinical update and results from both Ph3 2L DLBCL studies from BMS (Breyanzi; CD19 CAR-T) and Gilead (Yescarta; 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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No Significant Cell Therapy Updates in November’s CHMP Highlights; Celltelligence Reducing Ziopharm’s Coverage; UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

On Friday, November 12, the CHMP meeting highlights were released following Monday’s CHMP agenda, with no cell therapy-related updates observed. Recall that on Monday, November 8, 2021, the Celltelligence team prepared a full analysis on November’s CHMP agenda, discussing the potential timelines for Yescarta’s Type II variation in r/r FL and Tecartus’s Type II variation in r/r adult ALL, while providing an updated projected approval date for cilta-cel (see previous insight).

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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Will Yescarta Receive a Positive CHMP Opinion for R/R FL This Week? No Mention of Tecartus or Cilta-cel in November’s CHMP Agenda

On Monday, November 8, the CHMP agenda for November was released. Of note, Yescarta’s (Gilead’s CD19 CAR-T) Type II variation for ≥4L r/r FL is listed as ‘For Adoption’, while no updates were observed for Tecartus (Gilead’s CD19 CAR-T) in r/r adult ALL and cilta-cel (JNJ / Legend’s BCMA CAR-T) in r/r MM. Below, Celltelligence provides likely EU approval timelines for Yescarta, Tecartus, and cilta-cel.

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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New Yescarta Study in R/R DLBCL for Outpatient Administration

On Friday, November 5, a new investigator-initiated study evaluating Gilead (Kite)’s Yescarta (CD19 CAR-T) in the outpatient setting for r/r DLBCL was observed on CT.gov. Below, Celltelligence provides details for this trial, while discussing how this Yescarta outpatient study compares to key competitor Breyanzi (BMS’s CD19 CAR-T).

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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