SANTA MONICA, Calif.–(BUSINESS WIRE)–Feb. 10, 2020– Kite, a Gilead Firm (Nasdaq: GILD), at present introduced that the U.S. Meals and Drug Administration (FDA) has accepted the Biologics License Software (BLA) and granted Precedence Assessment designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell remedy for the therapy of grownup sufferers with relapsed or refractory mantle cell lymphoma (MCL).
The BLA is supported by knowledge from the only arm, open-label, Part 2 ZUMA-2 trial, which confirmed that 93 % of sufferers responded to a single infusion of KTE-X19, together with 67 % of sufferers reaching an entire response, as assessed by an Unbiased Radiologic Assessment Committee (IRRC; median follow-up of 12.three months). Within the security evaluation, Grade three or larger cytokine launch syndrome (CRS) and neurologic occasions had been seen in 15 % and 31 % of sufferers, respectively. No Grade 5 CRS or neurologic occasions occurred. Detailed findings from this trial had been not too long ago offered throughout an oral session on the 61st American Society of Hematology (ASH) Annual Assembly & Exposition in Orlando.
“Regardless of latest advances, sufferers with relapsed/refractory mantle cell lymphoma at present face a major lack of efficient therapy choices as soon as their illness now not responds to at present accessible remedy,” mentioned Ken Takeshita, MD, Kite’s World Head of Medical Growth. “Primarily based on the encouraging outcomes for KTE-X19, we’re wanting to proceed discussions with the FDA on methods to carry this progressive therapy to those sufferers who could profit from CAR T remedy.”
The Prescription Drug Person Price Act (PDUFA), or goal motion date, is August 10, 2020. The European Medicines Company (EMA) not too long ago validated the Advertising and marketing Authorization Software for KTE-X19 within the European Union. KTE-X19 has been granted Breakthrough Remedy Designation (BTD) by the FDA and Precedence Medicines (PRIME) designation by the EMA for relapsed or refractory MCL.
KTE-X19 is investigational and never but accredited in any nation globally. Its efficacy and security haven’t been established. A closing determination by the FDA is anticipated by August. Extra details about medical trials with KTE-X19 is on the market at
MCL is a uncommon type of non-Hodgkin lymphoma (NHL) that arises from cells originating within the “mantle zone” of the lymph node and sometimes impacts males over the age of 60.
ZUMA-2 is a single-arm, multicenter, open-label Part 2 research involving 74 enrolled/leukapheresed grownup sufferers (≥18 years outdated) with MCL whose illness is refractory to or has relapsed following as much as 5 prior traces of remedy, together with anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody remedy and the BTK inhibitors ibrutinib or acalabrutinib. The targets of the research are to judge the efficacy (60 sufferers) and security (68 sufferers) after a single infusion of KTE-X19 on this affected person inhabitants. The first endpoint for the research is goal response fee (ORR). ORR on this trial is outlined because the mixed fee of full responses and partial responses as assessed by an IRRC.
Secondary endpoints embrace length of response, progression-free survival, total survival, incidence of antagonistic occasions, incidence of anti-CD19 CAR antibodies, ranges of anti-CD19 CAR T cells in blood, ranges of cytokines in serum, and adjustments over time within the EQ-5D scale rating and visible analogue scale rating. The research is ongoing.
KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell remedy. KTE-X19 makes use of the XLP™ manufacturing course of that features T-cell choice and lymphocyte enrichment. Lymphocyte enrichment is a obligatory step in sure B-cell malignancies during which circulating lymphoblasts are a typical characteristic. KTE-X19 is at present in Part 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and persistent lymphocytic leukemia (CLL).
Kite, a Gilead Firm, is a biopharmaceutical firm primarily based in Santa Monica, California. Kite is engaged within the growth of progressive most cancers immunotherapies. The corporate is targeted on chimeric antigen receptor and T cell receptor engineered cell therapies. For extra data on Kite, please go to
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical firm that discovers, develops and commercializes progressive medicines in areas of unmet medical want. The corporate strives to rework and simplify take care of folks with life-threatening diseases world wide. Gilead has operations in additional than 35 international locations worldwide, with headquarters in Foster Metropolis, California. For extra data on Gilead Sciences, please go to the corporate’s web site at
This press launch consists of forward-looking statements, inside the which means of the Non-public Securities Litigation Reform Act of 1995 which can be topic to dangers, uncertainties and different components, together with the chance that FDA and the European Fee could not approve KTE-X19 for the therapy of grownup sufferers with relapsed or refractory MCL within the anticipated timelines or in any respect, and any advertising and marketing approvals, if granted, could have important limitations on its use. There may be additionally the opportunity of unfavorable outcomes from different ongoing and extra medical trials involving KTE-X19. All statements aside from statements of historic reality are statements that might be deemed forward-looking statements. These dangers, uncertainties and different components may trigger precise outcomes to vary materially from these referred to within the forward-looking statements. The reader is cautioned to not depend on these forward-looking statements. These and different dangers are described intimately in Gilead’s Quarterly Report on Kind 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Alternate Fee. All forward-looking statements are primarily based on data at present accessible to Gilead and Kite, and Gilead and Kite assume no obligation to replace any such forward-looking statements.
Supply: Kite, a Gilead Firm
Posted: February 2020
KTE-X19 FDA Approval Historical past