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FDA Investigating 'Serious Risk' of Malignancy After CAR-T Therapy - Applies to all approved therapies, but benefits still outweigh risks
The notice and investigation pertain to all currently approved BCMA- and CD19-targeted CAR T-cell products:[/i] [i] Axicabtagene ciloleucel (
Yescarta
)[/i] [i] Brexucabtagene autoleucel (Tecartus)[/i] [i] Ciltacabtagene autoleucel (Carvykti)[/i] [i] Lisocabtagene maraleucel (Breyanzi)[
The notice and investigation pertain to all currently approved BCMA- and CD19-targeted CAR T-cell products:[/i] [i] Axicabtagene ciloleucel (
Yescarta
)[/i] [i] Brexucabtagene autoleucel (Tecartus)[/i] [i] Ciltacabtagene autoleucel (Carvykti)[/i] [i] Lisocabtagene maraleucel (Breyanzi)[
cujoe
in
CLL Support
10 months ago
COVID update: Who remains at higher risk? by LLS.org
These include: • Bruton tyrosine kinase (BTK) inhibitors, such as Imbruvica® (ibrutinib), Brukinsa® (zanubrutinib) and Calquence® (acalabrutinib) • Anti-CD20 antibody treatments, such as Rituxan® (rituximab) and Gazyva® (obinutuzumab) • CD-19 targeting CAR T-therapy (Breyanzi®, Kymriah®, Tecartus™,
Yescarta
These include: • Bruton tyrosine kinase (BTK) inhibitors, such as Imbruvica® (ibrutinib), Brukinsa® (zanubrutinib) and Calquence® (acalabrutinib) • Anti-CD20 antibody treatments, such as Rituxan® (rituximab) and Gazyva® (obinutuzumab) • CD-19 targeting CAR T-therapy (Breyanzi®, Kymriah®, Tecartus™,
Yescarta
lankisterguy
Volunteer
in
CLL Support
2 years ago
COVID: Staying Safe As The Virus Evolves - LLS Podcast / CLL Society’s COVID-19 Update December 5th, 2022 / Dec 15 2022 end Antibody Study
These include: • Bruton tyrosine kinase (BTK) inhibitors, such as Imbruvica® (ibrutinib), Brukinsa® (zanubrutinib) and Calquence® (acalabrutinib) • Anti-CD20 antibody treatments, such as Rituxan® (rituximab) and Gazyva® (obinutuzumab) • CD-19 targeting CAR T-therapy (Breyanzi®, Kymriah®, Tecartus™,
Yescarta
These include: • Bruton tyrosine kinase (BTK) inhibitors, such as Imbruvica® (ibrutinib), Brukinsa® (zanubrutinib) and Calquence® (acalabrutinib) • Anti-CD20 antibody treatments, such as Rituxan® (rituximab) and Gazyva® (obinutuzumab) • CD-19 targeting CAR T-therapy (Breyanzi®, Kymriah®, Tecartus™,
Yescarta
lankisterguy
Volunteer
in
CLL Support
2 years ago
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LLS (Leukemia & Lymphoma Society) National Patient Registry Covid Vaccine guidelines
Patients who have had CAR T-therapy that targets the CD-19 protein (Breyanzi, Kymriah, Tecartus or
Yescarta
) should consider themselves immunosuppressed even if it has been more than two years from their treatment.
Patients who have had CAR T-therapy that targets the CD-19 protein (Breyanzi, Kymriah, Tecartus or
Yescarta
) should consider themselves immunosuppressed even if it has been more than two years from their treatment.
EPguy
in
MPN Voice
2 years ago
The LLS (USA) COVID-19 Vaccination Schedule - MODERATELY TO SEVERELY IMMUNOCOMPROMISED PATIENTS
Patients who have had CAR T-therapy that targets the CD-19 protein (Breyanzi, Kymriah, Tecartus or
Yescarta
) should consider themselves immunosuppressed even if it has been more than two years from their treatment.
Patients who have had CAR T-therapy that targets the CD-19 protein (Breyanzi, Kymriah, Tecartus or
Yescarta
) should consider themselves immunosuppressed even if it has been more than two years from their treatment.
lankisterguy
Volunteer
in
CLL Support
2 years ago
Axi-Cel (anti-CD19 CAR T-cell therapy FMC63-28Z) Induces Durable Remissions in Relapsed CLL, B-Cell Lymphoma
[i]Patients with relapsed chronic lymphocytic leukemia (CLL) and B-cell lymphoma who received the anti-CD19 CAR T-cell therapy FMC63-28Z, which was later developed as axicabtagene ciloleucel (axi-cel;
Yescarta
), experienced highly durable rates of remission, according to long-term data from a phase 1
[i]Patients with relapsed chronic lymphocytic leukemia (CLL) and B-cell lymphoma who received the anti-CD19 CAR T-cell therapy FMC63-28Z, which was later developed as axicabtagene ciloleucel (axi-cel;
Yescarta
), experienced highly durable rates of remission, according to long-term data from a phase 1
AussieNeil
Partner
in
CLL Support
4 years ago
CAR T-Cell Developments in Lymphoma Dr. Ian Flinn Highlights
The approval was based on findings from the phase II JULIET study, updated data of which showed an overall response rate (ORR) of 52%, with a complete response (CR) rate of 40%.1 - Previously, the FDA approved the CAR T-cell therapy axicabtagene ciloleucel (axi-cel;
Yescarta
) in October 2017 as a treatment
The approval was based on findings from the phase II JULIET study, updated data of which showed an overall response rate (ORR) of 52%, with a complete response (CR) rate of 40%.1 - Previously, the FDA approved the CAR T-cell therapy axicabtagene ciloleucel (axi-cel;
Yescarta
) in October 2017 as a treatment
lankisterguy
Volunteer
in
CLL Support
6 years ago
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