Teclistamab receives EMA conditional marketing authorization

Following its recommendation for conditional marketing approval from the Committee for Medicinal Products for Human Use (CHMP) in July 2022, on August 24, 2022, teclistamab was granted conditional marketing authorization from the European Commission as monotherapy for adult patients with relapsed/refractory multiple myeloma (RRMM).¹ This is based on the results of the MajesTEC-1 phase I/II trials (NCT03145181 and NCT04557098),¹ as covered previously by the Multiple Myeloma Hub (available here).

Teclistamab is licensed for patients who have previously been treated at least once with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, and have demonstrated progression on the last agent.¹ The announcement represents the first global approval of teclistamab for the treatment of RRMM, following an accelerated approval pathway supported by the European Medicines Agency Priority Medicines Program (PRIME). In addition, teclistamab is the first bispecific antibody approved for the treatment of MM.¹

Key findings from the MajesTEC-1 study include the following¹:

• The median progression-free survival was 11.3 months (95% confidence interval, 8.8–17.1).
• The median overall survival was 18.3 months (95% confidence interval, 15.1 – not estimable).

 No safety concerns were raised, and further efficacy and safety data can be found here.