Janssen marks first approval worldwide for Tecvayli
US healthcare giant Johnson & Johnson (NYSE: NJN) subsidiary Janssen today revealed that the European Commission (EC) has granted conditional marketing authorization (CMA) of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM).
Patients must have received 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.
Today’s milestone marks the first approval worldwide for teclistamab, a bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumor cells. The EC decision comes just a month after the European Medicines Agency’s human medicines committee (CHMP) made its recommendation for approval.
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