Tag Archives: CHMP

Breyanzi Absent from February’s CHMP Highlights

On Friday, February 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights implying that it has received a second RSI for its assessment in 2L LBCL. Below, Celltelligence provides updated EU approval timelines for Breyanzi.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Breyanzi Absent from December’s CHMP Agenda

On Monday, December 12, the CHMP agenda for December was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, December 16, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Breyanzi Absent from November’s CHMP Highlights

On Friday, November 11, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from November’s CHMP meeting. Below, Celltelligence provides updated EU timelines for Breyanzi.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Breyanzi Absent from November’s CHMP Agenda

On Monday, November 7, the CHMP agenda for November was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, November 11, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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

On Friday, October 14, the CHMP meeting highlights were released. In line with Monday’s CHMP agenda (see previous insight), no cell therapy-related updates were observed in October’s CHMP highlights.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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

On Monday, October 10, the CHMP agenda for October was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that Breyanzi’s (BMS’s CD19 CAR-T) indication extension to 2L LBCL transplant-intended (TI) patients could potentially be included in November’s CHMP agenda (see previous insight).

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

CHMP Adopts Positive Opinion for Yescarta; Breyanzi Absent from September’s CHMP Highlights

On Friday, September 16, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL. Additionally, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides insights on Yescarta’s positive opinion, while discussing updated EU timelines for Breyanzi.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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):

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.