Tag Archives: r/r FL

Thoughts on Kymriah’s ≥3L r/r FL Approval in Japan; Could Kymriah’s Price Decrease? Novartis’s APAC Market Expansion Strategy

On Friday, August 26, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Kymriah (Novartis’s CD19 CAR-T) for the treatment of r/r FL (press release). Below, Celltelligence provides insights on Kymriah’s potential pricing reduction in Japan, while discussing Novartis’s cell therapy expansion in the APAC market.

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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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CHMP Adopts Positive Opinion for Yescarta in ≥4L FL; Yescarta in 2L DLBCL Absent from April’s CHMP Meeting

On Friday, April 22, the CHMP meeting highlights were released following Tuesday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in ≥4L r/r FL. Additionally, Yescarta’s Type II variation for 2L DLBCL was absent from April’s CHMP meeting. Below, the Celltelligence team provides thoughts on Yescarta’s positive opinion in r/r FL, while providing updated EU timelines for Yescarta in 2L DLBCL.

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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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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

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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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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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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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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.

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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’s Sales Continue to Decline; Novartis Files Kymriah for R/R FL in the US and EU; Why is Novartis Prioritizing YTB323 in 2L DLBCL? Novartis Q3 2021 Earnings Call Summary

On Tuesday, October 26, Novartis held their Q3 2021 earnings presentation (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) continued sales decline and the US + EU regulatory submissions for Kymriah in r/r FL. Of note, management announced that in 2022, they intend to initiate a registrational trial for YTB323 (next-gen CD19 CAR-T) in 2L r/r DLBCL. Below, Celltelligence provides insights on Kymriah’s Q3 2021 sales revenue, while discussing likely US and EU approval timelines for Kymriah in r/r FL. Finally, Celltelligence outlines why declining Kymriah revenue doesn’t matter for a committed Novartis.

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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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