First approval worldwide for Tecvayli with EC authorisation of first-in-class bispecific antibody for the treatment of multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted conditional marketing authorisation (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. This milestone marks the first approval worldwide for teclistamab, a first-in-class bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells.
Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy. aAs the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.
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