The European Medicines Agency's CHMP positively recommended expanding the use of Johnson & Johnson's cancer drug, Talvey (talquetamab). The CHMP endorsed Talvey's use in combination with other therapies. This applies to adult patients with relapsed and refractory multiple myeloma who have undergone at least one prior line of therapy.
This recommendation moves Talvey to an earlier treatment stage. It could become a second-line option for a broader patient population in the European Union. Currently, Talvey is approved for patients who received at least three prior therapies. The recommendation stems from the Phase 3 MonumenTAL-3 study. This study showed significant improvements in progression-free survival.
The positive opinion is a key step. The European Commission will make a final decision on marketing authorization for the expanded indication. An approval would strengthen Johnson & Johnson's position in the competitive multiple myeloma treatment landscape.