Business
Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe
-- 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
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- 93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus --\n\n-- Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe --\n\n SANTA MONICA, Calif.--(BUSINESS WIRE)--\nKite, 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.\n\nThe 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 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent, with 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent and 33 percent of patients, respectively.\n\n“Significant gaps in treatment remain for patients with mantle cell lymphoma who progress following initial therapies,” said Professor John G. Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, London. “The availability of this first cell therapy for relapsed or refractory mantle cell lymphoma, following at least two lines of systemic therapy including a BTK inhibitor, provides an important option for patients in Europe.”\n\n“Kite is committed to bringing the curative intent potential of CAR T-cell therapy to patients with hematological cancers,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. We are proud our second cell therapy has been approved for use in E...