The FDA has approved idecabtagene vicleucel for the treatment of multiple myeloma

Share This Post

August 2021: The Food and Drug Administration approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) 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. This is the first cell-based gene therapy for multiple myeloma that has been approved by the FDA.

Idecabtagene vicleucel is a genetically engineered autologous chimeric antigen receptor (CAR) T-cell treatment that targets the B-cell maturation antigen (BCMA). Each dose is tailored to the patient’s own T-cells, which are harvested, genetically modified, and then reintroduced into the patient.

In a multicenter research, 127 patients with relapsed and refractory multiple myeloma who had undergone at least three prior lines of antimyeloma therapy were evaluated for safety and efficacy; 88 percent had received four or more prior lines of therapies. The efficacy of idecabtagene vicleucel at doses ranging from 300 to 460 x 106 CAR-positive T cells was studied in 100 individuals. The overall response rate (ORR), complete response (CR) rate, and duration of response (DOR) were calculated using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma by an independent response committee.

The ORR was 72 percent (95 percent CI: 62 percent, 81 percent), with a 28 percent CR rate (95 percent CI 19 percent , 38 percent ). A total of 65 percent of patients who attained CR stayed in it for at least a year.

A boxed warning for cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and persistent cytopenias is included on the idecabtagene vicleucel label. CRS, infections, exhaustion, musculoskeletal pain, and hypogammaglobulinemia are the most prevalent side effects of idecabtagene vicleucel.

Idecabtagene vicleucel has a risk evaluation and mitigation plan that requires healthcare facilities dispensing the medicine to be specially certified in recognising and managing CRS and nervous system toxicities. The FDA is ordering the company to conduct a post-marketing observational study involving patients treated with idecabtagene vicleucel in order to assess long-term safety.

300 to 460 106 CAR-positive T cells is the suggested dose range for idecabtagene vicleucel.

Reference : https://www.fda.gov/

Check details here:

Take second opinion on multiple myeloma treatment


Send Details

Apply for CAR T-Cell therapy


Apply Now

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient A case report
CAR T-Cell therapy

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient : A case report

Claudin18.2-targeted CAR-T cell therapy has shown remarkable potential in treating advanced pancreatic cancer, as highlighted in a recent case report. This innovative approach led to complete remission in a patient with advanced disease, underscoring the promise of targeted immunotherapy. By leveraging the specific expression of Claudin18.2 on cancer cells, this therapy offers a precision-based treatment, heralding a new era in pancreatic cancer management with significant clinical implications.

What is the treatment after BCMA CAR T failed in RR multiple myeloma cases
CAR T-Cell therapy

What is the treatment after BCMA CAR T failed in R/R multiple myeloma cases?

For people with relapsed or refractory multiple myeloma, BCMA CAR T-cell therapy might not work. Other treatments, such as bispecific antibodies, other CAR T-cell therapies that target different antigens, and combination regimens with immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies, can still be used. OriCAR-017 is another immunotherapy that is under trial and is expected to be launched soon. Clinical trials offer experimental treatments, providing access to novel therapies. Tailored approaches based on patient-specific factors and emerging research are crucial for improving outcomes in this challenging scenario.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy