Tag Archives: Tecartus

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 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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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).

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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 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.

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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’s Sales Decline; Gilead’s (Kite) New Manufacturing Facility in Maryland to Be Operational By Mid-2022; Health Canada Approves Tecartus in MCL; Gilead’s Q3 2021 Earnings Call Summary

On Thursday, October 28, Gilead held their Q3 2021 earnings call (press release / presentation) highlighting Yescarta’s (CD19 CAR-T) sales decline and the anticipated opening of their new manufacturing facility in Frederick County, Maryland. On the same day, Gilead announced (press release) that Health Canada has approved Tecartus (CD19 CAR-T) in r/r mantle cell lymphoma (MCL), based on results from the Ph2 ZUMA-2 trial. Below, Celltelligence provides insights on the potential impact of increased ATC competition on Yescarta’s Q3 sales revenue, while outlining likely US and EU approval timelines for Yescarta in 2L r/r DLBCL and Tecartus in r/r adult ALL. Finally, Celltelligence discusses Tecartus’s approval and reimbursement in Canada.

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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 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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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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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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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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Tecartus Website Analysis

On Wednesday, October 6, an update on Tecartus’s patient website was observed, with Gilead (Kite) now including Tecartus’s approval in r/r adult ALL. Below, Celltelligence provides an analysis on the updates included within the Tecartus website and insights into Tecartus’s messaging within the MCL and ALL setting.

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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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Gilead’s (Kite) Tecartus Receives FDA Approval for R/R Adult ALL

On Friday, October 1, Gilead (Kite) announced (press release) that the FDA has granted approval for Tecartus (CD19 CAR-T) in r/r adult ALL. Of note, Tecartus is the first approved CAR-T in the US for the treatment of adult ALL. Below, Celltelligence provides insights on how Tecartus’s approval in adult ALL compares with Kymriah’s pediatric and young adult ALL indication.

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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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Tecartus Receives FDA Approval for R/R Adult ALL

Late on Friday, October 1, Gilead (Kite) announced (press release) the US approval of Tecartus (CD19 CAR-T) in r/r adult ALL. Tecartus has become the first and only CAR-T therapy approved in r/r adult ALL. The Celltelligence team will be conducting a full analysis of Tecartus’s approval in the coming days.

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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