By Leah Sherwood - Last Updated: July 28, 2022
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization (CMA) for teclistamab as monotherapy for adult patients with relapsed/refractory (R/R) multiple myeloma (MM) 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 since last therapy.
The EMA’s CHMP recommendation is based on positive results from the multicohort, open-label, phase I/II MajesTEC-1 study evaluating the safety and efficacy of teclistamab in adults with R/R MM.
Teclistamab targets both B-cell maturation antigen (BCMA) and CD3. It works by redirecting CD3-positive T-cells to BCMA-positive myeloma cells, resulting in T-cell activation and subsequent lysis and death of BCMA-positive cells. This effect occurs regardless of T-cell receptor specificity or major histocompatibility complex class I molecules on the surface of the myeloma cells.
Source: BusinessWire via the Janssen Pharmaceutical Companies of Johnson & Johnson, July 2022
Original Source: Teclistamab Receives Positive Opinion From EMA for Adults with R/R Myeloma | Blood Cancers Today