CHMP recommends approval of Tecvayli in multiple myeloma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Tecvayli (teclistamab), from Janssen-Cilag International, recommending the granting of a conditional marketing authorisation for the medicinal product intended for treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies
Tecvayli will be available as 10 mg/ml and 90 mg/ml solutions for injection. The active substance of Tecvayli is teclistamab, a bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells. The benefit of Tecvayli is its ability to bring about a response in patients with relapsed and refractory multiple myeloma. The most common side effects are hypogammaglobulinaemia, cytokine release syndrome and neutropenia.
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