Tag Archives: cilta-cel

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 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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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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Cilta-cel US Delay to February 28, 2022

After market close today, November 1, 2021, Legend announced the PDUFA delay for cilta-cel to February 28, 2022, a delay of 3 months from the original action date of November 29, 2021. The news comes on the heels of bullish commentary from Legend’s October 18 R&D day (see previous insight) and JNJ’s Q3 2021 earnings on October 21 (see previous insight).

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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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BMS’s Breyanzi and Abecma Sales Increase; Could Abecma’s Continued Viral Vector Shortage Favor Cilta-cel’s Upcoming Launch? No Updates on GSK’s Cell Therapy Assets; BMS and GSK Q3 2021 Earnings Call Summaries

On Wednesday, October 27, BMS held their Q3 2021 earnings presentation (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) continued revenue growth. Furthermore, management commented that Abecma’s vector supply issues may not be fully resolved before H2 2022. On the same day, GSK presented their Q3 2021 financial results (press release / presentation). However, the company did not provide any updates on their cell therapy assets in development.

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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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JNJ Prepares for Cilta-cel’s Upcoming Approval; Could JNJ’s / Legend’s New Patient-Focused Digital Platform and Sales Force Strategy Position Cilta-cel for a Successful Launch?

On Thursday, October 21, FiercePharma published an article (publication) discussing cilta-cel’s launch strategy with Serge Messerlian, Janssen’s US Oncology President. Messerlian commented on JNJ’s / Legend’s plan to develop a digital platform for cilta-cel (BCMA CAR-T) while confirming that cilta-cel and Darzalex (JNJ’s CD38 antibody for r/r MM; daratumumab) will have separate sales teams. Below, Celltelligence provides insights on how JNJ / Legend could leverage Darzalex’s patient-focused digital platform and sales force team to increase patient referrals for cilta-cel upon approval.

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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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Cilta-cel on Track to Gain FDA Approval in Q4 2021; JNJ Q3 2021 Earnings Call Summary

On Tuesday, October 19, JNJ held their Q3 2021 earnings presentation (press release / presentation) highlighting cilta-cel’s (BCMA CAR-T) anticipated FDA approval by YE 2021. Below, Celltelligence provides insights on cilta-cel’s potential US and EU regulatory 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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Cilta-cel’s Potential Off-Label Use in the US; Could BMS’s KarMMa-3 Trial Design Limit Abecma’s Targetable Population? Legend / JNJ Pivot to Earlier Lines; Legend Explores Allogeneics, CAR-NKs, and Novel Solid Tumor Targets; Legend’s R&D Day

On Monday, October 18, Legend held an R&D day (presentation) detailing preclinical and clinical assets across their BCMA, allogeneic, and solid tumors programs. Below, Celltelligence provides insights on Legend’s LCM strategy for cilta-cel (BCMA CAR-T) and possible ‘off-label’ usage in the US, while discussing the company’s allogeneic and solid tumors platforms.

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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 Cell Therapy Updates in October’s CHMP Highlights

On Friday, October 15, the CHMP meeting highlights were released following Monday’s CHMP agenda. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed in October’s CHMP Highlights. Recall that on Wednesday, October 13, 2021, the Celltelligence team prepared a full analysis on October’s CHMP agenda, discussing Breyanzi’s continued regulatory delay and in-depth scenarios for EC approvals of the following cell therapy products (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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Thoughts on Breyanzi’s Continuing EU Regulatory Delays; Will Kymriah Receive a Positive CHMP Opinion for R/R FL in December 2021? No Updates for Tecartus, Cilta-cel, and Yescarta in October’s CHMP Agenda

On Monday, October 11, the CHMP agenda for October was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘List of outstanding issues (LoOI)’ section, while Kymriah (Novartis’s CD19 CAR-T) has been listed under ‘Type II variations’ to include ≥3L r/r FL as a new indication. No updates were observed for Tecartus (Gilead’s CD19 CAR-T), cilta-cel (JNJ / Legend’s BCMA CAR-T), or Yescarta (Gilead’s CD19 CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi and Kymriah.

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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 Tecartus Receive a Positive CHMP Opinion for R/R Adult ALL This Week? Cilta-cel Remains on Track for a November 2021 Opinion; No Mention of Breyanzi or Yescarta in September’s CHMP Agenda

On Monday, September 13, the CHMP agenda for September was released. Of note, Tecartus’s (Gilead’s CD19 CAR-T) Type II Variation for r/r adult ALL is listed as ‘For Adoption’, while cilta-cel (JNJ / Legend’s BCMA CAR-T) appears under the ‘List of Questions (LoQ)’ section. No updates were observed for Breyanzi (BMS’s CD19 CAR-T) in DLBCL or Yescarta (Gilead’s CD19 CAR-T) in FL. Below, Celltelligence provides likely EU approval timelines for Tecartus and cilta-cel.

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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