European approval for Kite’s CAR-T therapy Tecartus in elapsed or refractory mantle cell lymphoma

pharmafile | December 17, 2020 | News story | Sales and Marketing CAR-T, Europe, Gilead, Kite, Tecartus 

Gilead-owned Kite Therapeutics has secured marketing authorisation from the European Commission for its chimeric antigen receptor (CAR) T cell therapy Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19) in relapsed or refractory mantle cell lymphoma, a rare form of non-Hodgkin lymphoma.

The approval is conditional, awarded because, according to the Commission, “the benefit of immediate availability outweighs the risk of less comprehensive data available.”

The indication relates to adults who have previously received two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. This patient population is associated with poor prognosis, with patients showing a median overall survival of six to ten months.

The approval, made under Priority Review, was based on Phase II data evaluating the drug’s efficacy in trial participants 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. According to an analysis by an Independent Radiologic Review Committee, Tecartus demonstrated an overall response rate of 93% after a single infusion, with 67% of patients achieving a complete response.

“Significant gaps in treatment remain for patients with mantle cell lymphoma who progress following initial therapies,” commented Professor John G Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust in 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.”

Matt Fellows

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