Conditional European approval for Tecartus in mantle cell lymphoma

Following a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October, the European Commission has now granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19).

The drug was developed by Kite, now a subsidiary of Gilead Sciences (Nasdaq: GILD) as a result of its $11.9 billion acquisition in 2017.

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. However, full approval will have to be apllied for after one year, which will require additonal data to be submitted.