Tag Archives: Kymriah

CHMP Adopts Positive Opinions for Kymriah and Carvykti; Tecartus Absent From March’s CHMP Highlights

On Friday, March 25, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Kymriah (Novartis’s CD19 CAR-T) in ≥3L r/r FL and a positive conditional marketing authorization for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥4L r/r MM. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, the Celltelligence team provides thoughts on Kymriah’s and Carvykti’s positive opinion, while providing updated EU timelines for Tecartus.

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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 Carvykti Receive a CHMP Positive Opinion This Week? Type II Variations for Tecartus and Kymriah Listed in March’s CHMP Agenda

On Monday, March 21, the CHMP agenda for March was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) has been listed under ‘Initial applications; Opinions’. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) and Kymriah (Novartis’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r adult B-ALL and r/r FL, respectively. Below, Celltelligence provides insights on the potential EU approval timeline for Carvykti in r/r 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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Yescarta Absent From February’s CHMP Highlights

On Friday, February 25, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Yescarta’s absence from the CHMP highlights, while providing updated EU 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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Could Yescarta Receive a CHMP Positive Opinion for ≥4L FL This Week? Yescarta’s Evaluation for 2L DLBCL Listed in February’s CHMP Agenda

On Monday, February 21, the CHMP agenda for February was released. Of note, Yescarta’s (Gilead /Kite’s CD19 CAR-T) Type II Variations in ≥4L FL and 2L DLBCL are listed under ‘Type II Variations – Opinions or Requests for Supplementary Information’. No other cell therapy-related updates were observed. Below, Celltelligence provides insights on the potential EU approval timeline for Yescarta in ≥4L FL.

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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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Kymriah Sales Continue to Decline; Could an Approval in FL Offset Kymriah’s Revenue Loss in DLBCL? Novartis’s Q4 2021 Earnings Call Summary

On Wednesday, February 2, Novartis held their Q4 2021 earnings call (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) quarterly sales decline and regulatory submission in Japan for r/r FL. Below, Celltelligence provides insights on Kymriah’s Q4 2021 revenue, while discussing if Kymriah’s upcoming approvals in r/r FL will be enough to offset declining sales.

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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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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

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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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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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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

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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 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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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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