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Kites Tecartus (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe


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Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.
The conditional marketing authorization is supported from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antib ....

City Of , United Kingdom , United States , Santa Monica , Foster City , Ken Takeshita , Monica Tellado , Johng Gribben , Nathan Kaiser , Gilead Sciences , European Commission , Kite Global Head Of Clinical Development , Gilead Sciences Inc , Exchange Commission , Gilead Company , Radiologic Review Committee , Gilead Public Affairs , Gilead Company Nasdaq , Independent Radiologic Review Committee , Professor John , Consultant Haematologist , Medical Oncologist , Global Head , Priority Medicines , Special Warnings , Adverse Reactions ,

Kite's Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe


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93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus
Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe
Kite, a Gilead Company (NASDAQ:GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available. ....

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