Tag Archives: CHMP Agenda/Highlights

Obe-Cel Starts EMA Assessment in r/r B-ALL; April CHMP Agenda

On Monday, April 22, the CHMP Agenda for April was released. Of note, obe-cel (Autolus’s CD19 CAR-T) was included in the “Start of Procedure for New Application” section for the treatment of adult patients with r/r B-ALL.

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Obe-Cel Starts EMA Assessment in r/r B-ALL; April CHMP Agenda

On Monday, April 22, the CHMP Agenda for April was released. Of note, obe-cel (Autolus’s CD19 CAR-T) was included in the “Start of Procedure for New Application” section for the treatment of adult patients with r/r B-ALL.

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No Cell Therapy-Related Updates in March’s CHMP Agenda

On Monday, March 18, the CHMP Agenda for March was released. Of note, no cell therapy-related updates were observed. 

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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 Carvykti in ≥2L MM; February CHMP Highlights

On Friday, February 23, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM.

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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 Carvykti Receive a Positive Opinion in Q1 2024? February CHMP Agenda

On Monday, February 19, the CHMP agenda for February was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM.

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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 Abecma Receive a CHMP Positive Opinion on Friday?; January’s CHMP Agenda

On Monday, January 22, the CHMP agenda for January was released including Abecma (BMS / 2seventy bio’s BCMA CAR-T) in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while the Carvykti (JNJ / Legend’s BCMA CAR-T) Type II Variation for ≥2L MM was absent from the agenda.

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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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Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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 Carvykti Receive a Positive Opinion this Week? The Obe-cel Accelerate Assessment to Be Discussed for Adoption; December’s CHMP Agenda

On Monday, December 11, the CHMP Agenda for December was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM, while Abecma (BMS / 2seventy bio’s BCMA CAR-T) Type II Variation for ≥3L MM was absent from the agenda.

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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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Abecma T2V Receives a Second RSI; When Could Abecma and Carvykti Receive a Positive CHMP Opinion? November CHMP Highlights

On Friday, November 10, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights, implying that it has received a second Request for Supplementary Information (RSI) for its approval in ≥3L MM. Moreover, recall that the Carvykti (JNJ’s / Legend’s BCMA CAR-T) T2V in ≥2L MM was not included on Monday’s CHMP Agenda. Below, Celltelligence provides insights on the November CHMP meeting with updated EU timelines for both cell therapies.

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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No Cell Therapy-Related Updates in October’s CHMP Agenda

On Monday, October 9, the CHMP Agenda for October was released. Of note, no cell therapy-related updates were observed and both Type II Variations applications (T2V) for Abecma (BMS’s BCMA CAR-T) in ≥3L MM and Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM were absent from the agenda.

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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