Tag Archives: Yescarta

Type II Variations for Yescarta and Breyanzi Listed in September’s CHMP Agenda

On Monday, September 12, the CHMP agenda for September was released. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r DLBCL and high-grade B-cell lymphoma (HGBL), and 2L DLBCL Transplant Intended (TI) patients, respectively.

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Gilead / Kite Expands Cell Therapy Operations in Brazil, Singapore, and Saudi Arabia

On Wednesday, August 31, Gilead (Kite) announced the expansion of their cell therapy operations to Brazil, Singapore, and Saudi Arabia (press release). Below, Celltelligence provides insights on how Yescarta (Kite’s CD19 CAR-T) could quickly challenge Kymriah’s (Novartis’s CD19 CAR-T) market exclusivity in these geographies, while discussing Kite’s potential manufacturing expansion strategy.

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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 Cell Therapy-Related Updates in August’s CHMP Agenda

On Tuesday, August 16, the CHMP agenda for August was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that for the CHMP meetings from June and July 2022, the Celltelligence team prepared two full analyses providing the following EC approval timelines for Breyanzi (BMS’s CD19 CAR-T) and Yescarta (Gilead / Kite’s CD19 CAR-T):

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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 Reports Outstanding Cell Therapy Revenue Growth; Yescarta’s Manufacturing Capacity Scaled to Address Demand; Updated Regulatory Milestones for Yescarta and Tecartus in the EU; Gilead’s Q2 2022 Earnings Call Summary

On Tuesday, August 2, Gilead (Kite) held their Q2 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing EU regulatory milestones for Yescarta and Tecartus (CD19 CAR-Ts). Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how Gilead’s manufacturing strategy could accommodate Yescarta’s expected increase in demand.

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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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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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CHMP Adopts Positive Opinion for Tecartus; Yescarta Absent From July’s CHMP Highlights

On Friday, July 22, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL. Additionally, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Tecartus’s positive opinion, while discussing updated EU timelines for Yescarta.

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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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Type II Variations for Yescarta and Tecartus Listed in July’s CHMP Agenda

On Monday, July 18, the CHMP agenda for July was released. Of note, Yescarta and Tecartus (Gilead / Kite’s autologous CD19 CAR-Ts) have been listed as ‘For adoption’ under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for 2L LBCL and r/r adult B-ALL, respectively.

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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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New Yescarta Ph2 Trial (ZUMA-24) for 2L LBCL in the Outpatient Setting Posted

On Friday, July 15, a new Kite-sponsored Ph2 trial (ZUMA-24) evaluating the outpatient administration of Yescarta (CD19 CAR-T) in 2L LBCL was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing how Yescarta’s outpatient treatment strategy compares with key competitor Breyanzi (BMS’s CD19 CAR-T).

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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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Breyanzi Included in the NCCN Guidelines for the Treatment of 2L DLBCL

On Tuesday, July 12, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas were updated (NCCN Guidelines in B-Cell Lymphoma) to include Breyanzi’s (BMS’s CD19 CAR-T) treatment in 2L DLBCL. Of note, Breyanzi is now recommended as a 2L therapy for patients who have primary refractory disease or have relapsed within 12 months, as well as patients who are non-candidates for transplant. Below, Celltelligence provides insights on Breyanzi’s inclusion in the NCCN Guidelines, while discussing how Yescarta’s (Gilead / Kite’s CD19 CAR-T) NCCN recommendation.

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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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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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