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Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) With EC Authorisation of Bispecific Antibody for the Treatment of Patients With Multiple Myeloma

BEERSE, BELGIUM, 24 August 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 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.1 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 tumour cells.1
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