US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen today revealed that the European Commission (EC) has granted the approval of a Type II variation application for Tecvayli (teclistamab).
This provides the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.1
Teclistamab, a bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells, and CD3 on T-cells, won its first approval in Europe for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) 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 on the last therapy.
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