TALVEY® (talquetamab), a bispecific antibody that targets GPRC5D, has shown promising results in the treatment of relapsed and refractory multiple myeloma (RRMM). The European Commission has granted conditional marketing authorization for TALVEY® (talquetamab) as a monotherapy for adult patients with RRMM who have received three previous therapies. The approval is based on positive results from the Phase 1/2 MonumenTAL-1 study, which demonstrated overall response rates of more than 70 percent. Talquetamab is a bispecific T-cell engaging antibody that targets CD3 and GPRC5D, a protein expressed on multiple myeloma cells.

The drug is administered weekly or biweekly via subcutaneous injection. Patients in the study achieved significant responses, including very good partial responses and complete responses. The responses were durable, and a substantial percentage of patients maintained a response for at least nine months.The study also included patients who had received prior T-cell redirection therapy, with positive outcomes observed in this subgroup. The most common adverse events were manageable and included cytokine release syndrome, dysgeusia, and hypogammaglobulinemia. The European approval follows the FDA approval of talquetamab for the same indication in the United States. Read the full press release from Janssen Pharmaceuticals (a Johnson & Johnson company) to learn more.