Gilead Tecartus treatment package lymphoma is eligible for European approval

Recently, Gilead subsidiary Kite Pharmaceuticals announced that the European Commission has granted CAR-T cell therapy Tecartus (formerly KTE-X19) a conditional marketing license.
Tecartus is an autobiographic anti-CD19, inlay antigen-subject T-cell therapy (CAR-T) for adult patients with recurring or refractic heterocytic heterocytic lymphoma after two or more systematic treatments, including Bruton tyrosine kinase BTK inhibitors.
October, the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) issued an active review of the drug.
that the drug was granted conditional sales authorization for public health reasons, i.e. the regulator assessed that tecartus had the benefit of immediate availability over the risk of lack of comprehensive data.
Tecartus' decision to obtain a sales license was supported by a single-arm, multi-center, phase 2 open-label ZUMA-2 critical cross-border clinical trial in adult patients with R/R MCL, who had a disease that was ineffective or re-emerged in five previous treatment options (including chemotherapy based on cyclocyclycides or benzodiaxine, anti-CD20 monoclonal antibody drugs, BTK inhibitors ibroxinib or acarutinib).
results showed that the overall remission rate (full or partial) of ZUMA-2 was 93%, with 67% of patients achieving complete remission after a single infusion of Tecartus.
safety analysis, level 3 or higher cytokine release syndrome (CRS) and neuro-reactive events were observed in 15% and 33% of patients, respectively.
G. Gribben, a hematologist and oncologist at Barts london and London NHS Trust, said: "There are still significant gaps in treatment for patients with heterocytic lymphoma who have progressed since the initial treatment.
the availability of this cell therapy provides an important treatment option for patients in Europe who have been treated with recurring or refractic sleeve lymphoma after at least two BTK inhibitors.
" set of lymphoma is a relatively rare non-Hodgkin's lymphoma, originating in the lymph nodes "set" of cells, mainly affecting men over 60 years of age.
cell lymphoma will be highly aggressive if it relapses, and the patient's condition will continue to progress during treatment.
patients who received two or more systemic therapies (including BTK inhibitors) had poor prognostication and a medium total survival of only 6 to 10 months.
, it is estimated that at least 7,400 people are diagnosed with lymphoma each year.
Tecartus uses an XLP manufacturing process that includes T-cell screening and lymphocyte aficionion.
is a necessary step for some B-cell malignancies with evidence of circulating lymphocytes.
a conditional drug marketing authorization issued by European regulators is initially valid for one year, but can be extended or converted to an unlimited marketing authorization after other confirmation data has been submitted and evaluated.
approved drugs can fill unseeded medical needs, Kite Pharmaceuticals needs to provide more Tecartus efficacy monitoring and post-market data before the drug can be fully approved.
source: Kite's Tecartus ™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe