EC Grants Conditional Marketing Authorization for Teclistamab in Myeloma

By Cecilia Brown - Last Updated: October 13, 2022

The European Commission (EC) has granted Conditional Marketing Authorization (CMA) for teclistamab as a monotherapy for the treatment of adults with relapsed/refractory multiple myeloma (MM). The drug’s use under the CMA is limited to adults with relapsed/refractory MM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression with their most recent line of therapy.

This is first approval worldwide of the drug, officials said. The CMA in the European Union (EU) will be valid for one year and can be renewed annually. It can be converted into a Standard Marketing Authorization once certain obligations are fulfilled and data show that the benefit of the drug outweighs its risk, according to the EC.

Teclistamab is a first-in-class bispecific antibody that redirects CD3-positive
T cells to B-cell maturation antigen-expressing myeloma cells to induce tumor cell death.

The CMA approval follows the multicohort, open-label, phase I/II MajesTEC-1 study that evaluated the safety and efficacy of teclistamab in 165 adults with relapsed/refractory MM. A very good partial response or better was reported in 58.8% of patients, and a complete response was reported in 39.4% of patients in the study.

Source: Business Wire, August 2022

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