Tag Archives: Kymriah

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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Abecma’s Sales Increase While Breyanzi’s Revenue is Affected by Manufacturing Issues; No Clinical Milestone Updates for Breyanzi or Abecma; Oxford Biomedica’s Expanded LSA Agreement; BMS’s Q2 2022 Earnings Call Summary

On Wednesday, July 27, BMS held their Q2 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales decrease and US approval in 2L LBCL. Moreover, management reported a revenue increase for Abecma (BCMA CAR-T). Of note, no updated clinical milestones for Breyanzi and Abecma were observed. Below, Celltelligence provides insights on how Breyanzi and Abecma revenue compares with key competitors Kymriah (CD19 CAR-T; Novartis), Yescarta (CD19 CAR-T; Gilead / Kite), and Carvykti (BCMA CAR-T; JnJ / Legend). Additionally, Celltelligence discusses BMS’s LSA expansion agreement with Oxford Biomedica.

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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’s Sales Remain Flat After US and EU Approvals in ≥3L FL, PHE885’s Submission Delayed to 2025; YTB323’s Development Strategy Being Updated; Novartis Q2 2022 Earnings Call Summary

On Tuesday, July 19, 2022, Novartis held their Q2 2022 earnings call (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) approval in ≥3L FL, both in the US and EU. Additionally, PHE885’s (T-Charge BCMA CAR-T) submission has been delayed to 2025, while YTB323’s (T-Charge CD19 CAR-T) Ph3 trial development strategy is under review. Below, Celltelligence provides insights on Novartis’s potential strategies to increase Kymriah’s revenue, while discussing if the company could use their recently acquired Priority Review Voucher to accelerate their T-Charge programs.

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Novartis (Blast 2/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. Below, Celltelligence provides part 2 of its analysis on Novartis’s pipeline, manufacturing technology, CDMO potential, and collaborative strategy to remain a leader in the space. In subsequent blasts, Celltelligence will provide a similar overview for BMS and Gilead (Kite). At the end of the series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Novartis (Blast 1/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. Below, Celltelligence provides a two-part analysis on Novartis’s pipeline, manufacturing technology, CDMO potential, and collaborative strategy to remain a leader in the space. In subsequent blasts, Celltelligence will provide a similar overview for BMS and Gilead (Kite). At the end of the six-part series, Celltelligence will present a semi-qualitative analysis comparing the innovative strategies from Novartis, BMS, and Gilead (Kite).

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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UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated its CD19 CAR-T indications table for estimated US approvals and submissions following key Q1 2022 earnings presentations and recent press releases (see below for download).

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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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Novartis Presents Updated Results for T-Charge Assets PHE885 and YTB323; A Comparative Analysis Demonstrates Kymriah’s Safety Superiority Over Yescarta in R/R FL; EHA 2022 Analysis 1

EHA 2022 Analysis 1: Novartis presented clinical updates for two T-Charge assets and a comparative study of Kymriah and Yescarta in r/r FL was reported. Below, Celltelligence provides insights and context for key selected presentations. 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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Kymriah Receives FDA Approval for R/R FL After Two or More Lines of Systemic Therapy

Late on Friday, May 27, Novartis announced (press release) that the FDA granted accelerated approval for Kymriah (CD19 CAR-T) in ≥3L r/r FL. Kymriah is the second CAR-T to be approved by the FDA in r/r FL. Of note, Kymriah’s FDA approval was based on results from the Ph2 ELARA trial, with 86% and 68% of patients achieving an ORR and CR, respectively. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days (link to PI).

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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Kymriah’s Sales Decline; PHE885 Pivotal Study Initiated; YTB323’s Anticipated Submission Delayed to 2025; Novartis’s Q1 2022 Earnings Call Summary

On Tuesday, April 26, 2022, Novartis held their Q1 2022 earnings call (press release / presentation) highlighting a decline in Kymriah’s (CD19 CAR-T) sales. Additionally, management noted Kymriah’s positive CHMP opinion in ≥3L FL, PHE885’s (T-Charge BCMA CAR-T) Ph2 trial initiation in 4L MM, and YTB323’s (T-Charge CD19 CAR-T) delayed regulatory filing in 2L DLBCL. Below, Celltelligence provides insights on Kymriah’s Q1 2022 revenue, while discussing YTB323’s delayed submission.

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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 and Kymriah Product Attributes; Early Results from Gracell’s GC502 Ph1 Study in r/r B-ALL; Legend’s LB1901 Ph1 Study Design in r/r TCL; AACR 2022 Analysis 3

AACR 2022 Analysis 3: Several clinical updates were presented by Gilead, Novartis, Gracell, and Legend. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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