The first CAR-T treatment for inert non-Hodgkin's lymphoma is expected to be available

On May 5, Gilead Sciences Inc.'s Kite Corporation announced that it has submitted to the FDA a request for a complementary biological product license (sBLA) for car-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of patients with recurring/refractic follicle lymphoma and marginal lymphoma who have received more than two systemic treatments.
Yescarta has previously been recognized by the FDA as a breakthrough therapy for these adaptations.
, Yescarta would be the first CAR-T cell therapy approved for the treatment of relapsed/resuscidable inert non-Hodgkin's lymphoma (NHL), according to a press release.
glial lymphoma and marginal lymphoma are both inert NHL, and the patient's malignancies grow slowly, but become more aggressive over time.
lymphoma is the most common inert lymphoma and the second most common type of lymphoma in the world.
accounts for about 22 percent of the world's diagnosed lymphoma.
lymphoma is the third most common lymphoma, accounting for 8%-12% of all B-cell NHL.
currently, there is no standard treatment for relapsed/refractive folytic lymphoma after receiving two or more lines of therapy, and there are limited treatment options for relapsed/refractive marginal lymphoma.
Yescarta is the FDA-approved second CAR-T cell therapy for adult patients with relapsed/refractic large B-cell lymphoma.
it directs and activates T-cells to kill cancerous B-cells by targeting CD19 antigens on the surface of B cells.
the submission of the sBLA is supported by key analytical data from phase 2 clinical trial ZUMA-5, which is being presented to the upcoming Scientific Conference.
results from an interim analysis of ZUMA-5 were released this year at the annual meeting of the American Society of Clinical Oncology (ASCO).
-term analysis showed that when the medium follow-up time reached 11.5 months, the total remission rate of 96 patients with inert non-Hodgkin's lymphoma who were able to evaluate the efficacy reached 93%, of which the total remission rate reached 80%.
Ken Takeshita, head of global clinical development at Kite, said: "Inert NHL patients begin with slow progress, but over time each recurrence becomes more aggressive.
observed in ZUMA-5 may provide a potentially transformative treatment option for certain types of inert NHL high-risk patients.
look forward to working closely with the FDA to bring Yescarta to inert NHL patients as soon as possible.
" References: . . . Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Yescarta® in Relapsed or Refctorray Indolent Non-Hodgkin Lymphomas. Retrieved September 4, 2020, from Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R INHL). Retrieved September 4, 2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .