EMA committee recommends new talquetamab treatment combinations for relapsed or refractory myeloma
Latest news
On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) recommended extending the approved use of talquetamab (Talvey®) to include combinations with daratumumab, either alone or together with pomalidomide, for myeloma patients who have received at least one previous line of treatment.
The CHMP is the European Medicines Agency’s (EMA) committee responsible for evaluating medicines and recommending whether medicines should be approved in the European Union. A positive recommendation from the CHMP still requires formal approval by the European Commission before it can be implemented. This process typically takes a few months.
Talquetamab is a targeted immunotherapy that binds to the GPRC5D protein on myeloma cells and helps the immune system’s T cells to recognise and kill myeloma cells.
The CHMP recommendation is based on the results of the phase III MonumenTAL-3 study, published in the New England Journal of Medicine. The study showed that patients treated with talquetamab plus daratumumab, with or without pomalidomide, lived longer without their myeloma getting worse than patients treated with daratumumab, pomalidomide and dexamethasone. Click here to watch a patient-friendly video explaining the study, its results and what they could mean for myeloma patients.
Talquetamab is currently authorised as monotherapy (on its own) for myeloma patients who have received at least three previous treatments, including an immunomodulatory agent (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib or carfilzomib), and an anti-CD38 monoclonal antibody (e.g. daratumumab or isatuximab), and whose disease has worsened despite their most recent treatment.
It would also mark the first time a GPRC5D-targeting bispecific antibody could be used as a second-line myeloma treatment in the European Union.
Following European Commission approval, treatment availability will depend on pricing, reimbursement and access decisions in individual European countries.
Â
Â