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News
The EMA's CHMP has recommended expanding the use of talquetamab (Talvey) in combination with daratumumab — with or without pomalidomide — for adults with relapsed/refractory multiple myeloma after at least one prior line of therapy. The recommendation is backed by phase 3 MonumenTAL-3 trial data showing a 72% reduction in the risk of progression or death compared to standard care. The European Commission will make the final approval decision.
Europe's drug advisory committee just gave a significant nod to a powerful new myeloma combination. The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication for talquetamab (Talvey) to include its use alongside daratumumab (Darzalex), with or without pomalidomide, in adults with relapsed/refractory multiple myeloma who've had at least one prior line of therapy. The European Commission will make the final call on approval.
The recommendation is grounded in data from the phase 3 MonumenTAL-3 trial, which evaluated a regimen that simultaneously targets two key proteins — GPRC5D and CD38 — on myeloma cells. The triple combo of talquetamab + daratumumab + pomalidomide (Tal-DP) cut the risk of progression or death by 72% vs. the standard daratumumab + pomalidomide + dexamethasone (DPd) regimen. The two-drug combo (Tal-D) wasn't far behind, reducing that risk by 67%.
By the Numbers:
Why it matters: For myeloma patients facing their first relapse, this immunotherapy combination offers significantly deeper and more durable responses than current standard of care — potentially reshaping how early relapsed disease is managed across Europe.
