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News
The EMA's CHMP has recommended expanding teclistamab's (Tecvayli) approval to cover adult patients with relapsed/refractory multiple myeloma after just one prior therapy. The recommendation is backed by striking phase 3 MajesTEC-9 data showing a 71% reduction in disease progression or death vs. standard care. The European Commission will make the final call on the expanded authorization.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending that teclistamab (Tecvayli) monotherapy be approved for adult patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy — a significant step toward earlier use of the bispecific antibody. The final decision now rests with the European Commission.
The recommendation is anchored in data from the phase 3 MajesTEC-9 trial, which enrolled 593 patients with 1–3 prior lines of therapy. Teclistamab dramatically outperformed standard-of-care regimens (PVd or Kd) across every key endpoint, with a median PFS that was not yet reached in the teclistamab arm at 17.3 months of follow-up.
By the Numbers:
Why it matters: This CHMP opinion could reshape the multiple myeloma treatment landscape in Europe by bringing a potent immunotherapy option to patients much earlier in their disease course, potentially improving long-term outcomes for a broader population.
