The European Medicines Agency (EMA) has approved Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
The EMA has reviewed the safety and efficacy data for Tecartus from a multicentre clinical trial in adult patients with refractory or relapsed MCL. Among 74 patients who received Tecartus and were followed up for 12 months, the objective response rate (ORR) was 84 per cent and the complete response (CR) rate was 59 per cent.
The most common side effects were cytokine release syndrome (CRS), infections and encephalopathy.
In its overall assessment of the available data, the EMA’s Committee for Advanced Therapies (CAT) concluded that the benefits of Tecartus outweighed the possible risks.
The EMA’s opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.