EC Grants Conditional Marketing Authorization to Janssen’s Tecvayli for Multiple Myeloma

The European Commission (EC) has granted conditional marketing authorization for Janssen’s  Tecvayli (teclistamab) for treatment of adult patients with relapsed and refractory multiple myeloma.

The drug is specifically authorized for patients who have gone through at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Tecvayli is a bispecific antibody that binds to a protein expressed on the surface of T cells and an antigen expressed on the surface of myeloma cells.

The authorization was based on results from a phase 1/2 study in which patients who received a weekly subcutaneous injection of teclistamab achieved an overall response rate of 63 percent.