Tag Archives: sBLA

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 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 Files an sBLA for Yescarta in 2L R/R DLBCL

On Thursday, September 30, Gilead (Kite) announced (press release) that they have submitted an sBLA to the FDA for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Of note, Yescarta’s sBLA application is supported by data from the Ph3 ZUMA-7 trial in 2L r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s estimated FDA approval timeline for 2L r/r DLBCL, while discussing how Breyanzi (BMS) and Kymriah (Novartis) compare in the 2L 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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Comparison of Kymriah’s and Breyanzi’s Efficacy Profile; Gilead Presents Updated Results from Tecartus’s Ph1/2 ZUMA-3 (ALL) and Ph2 ZUMA-2 (MCL) Trials; ASCO 2021 Day 1

On the first day of ASCO 2021, four key clinical updates were presented from Novartis and Gilead. Below, Celltelligence provides insights and context for each presentation.

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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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