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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Multiple Myeloma |
| Drug: | Abecma (idecabtagene vicleucel) (BCMA-targeted CAR-T immunotherapy) |
| Direction: | Sensitive |
Evidence:
Published date:
04/05/2024
Excerpt:
Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc...(FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy...
Trial ID:
Title:
Bristol Myers Squibb's Abecma® Becomes First CAR T Approved for Use in Earlier Lines of Therapy for Patients with Relapsed or Refractory Multiple Myeloma in Japan
Published date:
12/06/2023
Excerpt:
Bristol-Myers Squibb K.K. announced that the company has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma® (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
Title:
Bristol Myers Squibb Receives Approval for Abecma (idecabtagene vicleucel), the First CAR T Therapy Approved for the Treatment of Multiple Myeloma in Japan
Published date:
01/20/2022
Excerpt:
Bristol-Myers Squibb K.K...announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have either experienced disease progression on the last therapy or relapse after the last therapy.
Title:
Bristol Myers Squibb Receives European Commission Approval for Abecma (Idecabtagene Vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma
Published date:
08/19/2021
Excerpt:
Bristol Myers Squibb...today announced that the European Commission (EC) has granted Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Source:
Title:
Health Canada Approves ABECMA (idecabtagene vicleucel), the First and Only Anti-BCMA CAR T cell Therapy for Relapsed and Refractory Multiple Myeloma
Published date:
05/31/2021
Excerpt:
Bristol Myers Squibb Canada (BMS) today announced Health Canada has granted conditional approval (NOC/c) for ABECMA (idecabtagene vicleucel; ide-cel) as the first and only B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for adults with multiple myeloma (MM).
Title:
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
Published date:
03/26/2021
Excerpt:
Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with 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.
Source:
Published date:
04/12/2021
Excerpt:
Therapy for previously treated Multiple Myeloma…Other recommended regimens…Idecabtagene vicleucel.
Title:
Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma (idecabtagene vicleucel)in Earlier Lines of Therapy for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma
Published date:
01/26/2024
Excerpt:
...Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization approval of Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
Title:
Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma (idecabtagene vicleucel) Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma
Published date:
08/10/2022
Excerpt:
Bristol Myers Squibb...announced positive topline results from KarMMa-3, a Phase 3, global, randomized, multicenter, open-label study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy and refractory to the last regimen....Results from the KarMMa-3 study clearly demonstrate the clinical benefit of using a CAR T cell therapy earlier in the multiple myeloma treatment paradigm.
Trial ID:
Source:
Title:
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
Published date:
09/22/2020
Excerpt:
...Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
