CAR-T in Multiple Mmyeloma,What are the CAR-T therapies approved by FDA and pending approval in 2024
CAR-T in Multiple Mmyeloma,What are the CAR-T therapies approved by FDA and pending approval in 2024
Currently, the FDA has approved six CAR-T cell therapies
Tisagenlecleucel (Kymriah)
– Indications: Acute lymphoblastic leukemia, B-cell lymphoma, follicular lymphoma
– Target: CD19
– Developer: Novartis
– Initial approval date: August 30, 2017
Tisagenlecleucel (trade name Kymriah) is used to treat B-cell acute lymphoblastic leukemia (ALL).
Tisagenlecleucel was originally invented by the University of Pennsylvania and developed by Novartis. It received its first FDA approval on August 30, 2017, becoming the first FDA-approved CAR-T therapy in the United States.
Axicabtagene Ciloleucel (Yescarta)
– Indications: B-cell lymphoma, follicular lymphoma
– Target: CD19
– Developer: Kite Pharma Inc.
– Initial approval date: October 18, 2017
Brexucabtagene Autoleucel (Tecartus)
– Indications: Relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL), relapsed/refractory mantle cell lymphoma (r/r MCL)
– Target: CD19
– Developer: Kite Pharma, Inc
– Initial approval date: July 24, 2020
Lisocabtagene Maraleucel (Breyanzi)
– Indications: Large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and Grade 3B follicular lymphoma
– Target: CD19
– Developer: BMS
– Initial approval date: February 5, 2021
Idecabtagene Vicleucel (Abecma)
– Indication: Relapsed or refractory multiple myeloma (after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody)
– Target: BCMA
– Developer: Celgene Corporation (subsidiary of BMS)
– Initial approval date: March 26, 2021
Ciltacabtagene autoleucel (Carvykti)
– Indication: Multiple myeloma
– Target: BCMA
– Developer: Janssen Biotech, Inc
– Approval date: February 28, 2022
CAR-T Therapies Pending Approval in 2024
Carvykti (ciltacabtagene autoleucel, cilta-cel)
– BLA Attribute: New indication
– Indication: Cancer – For the treatment of adults with relapsed or refractory multiple myeloma after receiving at least one prior therapy (including a proteasome inhibitor and an immunomodulatory agent)
– Target: BCMA
– Developer: Janssen and Legend Biotech
– BLA Type: Standard Review
– PDUFA Date: April 5, 2024
Breyanzi (lisocabtagene maraleucel)
– BLA Attribute: New indication
– Indication: Cancer – For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL)
– Target: CD19
– Developer: BMS
– BLA Type: Priority Review
– PDUFA Date: May 23, 2024
Breyanzi (lisocabtagene maraleucel)
– BLA Attribute: New indication
– Indication: Cancer – For the treatment of adult patients with mantle cell lymphoma (MCL) relapsed or refractory after Bruton’s tyrosine kinase inhibitor therapy
– Target: CD19
– Developer: BMS
– BLA Type: Priority Review
– PDUFA Date: May 31, 2024
Obecabtagene autoleucel (obe-cel)
– BLA Attribute: New therapy
– Indication: For the treatment of relapsed or refractory adult B-cell acute lymphoblastic leukemia (ALL)
– Target: CD19
– Developer: Autolus Therapeutics
– BLA Type: Standard Review
– PDUFA Date: November 16, 2024
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