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The FDA has announced approval of the listing of the CAR-T treatment Breyanzi (lisocabtagene maraleucel), developed by Juno Therapeutics, a subsidiary of BMS, for the treatment of certain adult patients with large B-cell lymphoma who do not respond to at least two other systemic treatments or relapse after treatment.
Breyanzi is a CAR-T cell therapy that targets CD19 antigens and is FDA-approved Type 4 CAR-T therapy.
diffuse large B-cell lymphoma (DLBCL) is the most common malignant lymphoma in the world and an invasive form of non-Hodgkin's lymphoma (NHL).
30 to 40 percent of DLBCL patients who received first-line treatment did not get relief or the disease returned.
who are unable to receive first-line treatment and are not suitable for high-dose chemotherapy (HDC) and self-stem cell transplantation (ASCT) have poor prognosis and urgently need more treatment options.
Breyanzi is an auto-CAR-T therapy that targets CD19 antigens.
it has been awarded a breakthrough therapy award by the FDA and an Advanced Therapy for Regenerative Medicine (RMAT).
unique to this therapy is that the ratio of CD8-positive to CD4-positive T-cells in CAR-T therapy is controlled to better control the toxic side effects of cell therapy.
application is based on efficacy and safety data from a clinical trial called TRANSCEND NHL 001.
results showed that 54 percent of the more than 250 patients assessed achieved complete remission (CR).
" approval represents another milestone in gene therapy, providing additional treatment options for certain cancer patients with cancers that affect blood, bone marrow and lymph nodes.
Peter Marks, director of the FDA's Center for Biological Evaluation and Research, said, "Gene and cell therapy has evolved from a promising concept to a practical cancer treatment.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
a reference: . Retrieved February 5, 2021, from
