JNJ 64407564 filed with EU for multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of JNJ 64407564 (talquetamab) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM)
Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and CD3 on T-cells.
This MAA is supported by data from the Phase I/II, first-in-human MonumenTAL-1 study of talquetamab (Phase 1: NCT03399799; Phase II: NCT04634552) in patients with RRMM who have received more than three prior lines of therapy. The first Phase II results from the study were presented at the 2022 American Society of Hematology (ASH) Annual Meeting in an oral scientific session (Abstract #157). These data were featured as part of the ASH Press Briefing and were selected to participate in the Best of ASH session, which highlights key scientific and clinical themes presented during the meeting. Results from the Phase 1 portion of the MonumenTAL-1 study were recently published in The New England Journal of Medicine.
See-VOL. 387 NO. 24, DEC 15, 2022;"Talquetamab, a T-Cell–Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma"- A. Chari and Others.N Engl J Med 2022; 387:2232-2244.