The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Janssen’s Talvey (talquetamab).
The drug has received a positive opinion for use as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Talquetamab is a subcutaneous bispecific antibody that binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells.
The CHMP also recommended the approval of a Type II variation for teclistamab, providing a reduced, biweekly dosing schedule of 1.5mg/kg every other week in patients who have achieved a complete response or better for six months or longer.
Teclistamab is the first bispecific antibody targeting B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells to be licensed in Europe for the treatment of adult patients with RRMM who have had at least three prior therapies.
Edmond Chan, Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited, said: “Today’s recommendation from the CHMP marks an exciting step for patients who continue to face the challenges of this difficult-to-treat blood cancer. We look forward to working with health authorities to bring talquetamab to patients in need across the region as soon as possible, while we continue our focus on enhancing a robust multiple myeloma portfolio of therapeutics and regimens.”
The recommendation for talquetamab is based on data from the Phase I/II MonumenTAL-1 study, while the recommendation for teclistamab is based on data from the Phase I/II MajesTEC-1 study.
