JNJ 64407564 filed with FDA for multiple myeloma.- Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the FDA for JNJ 64407564 (talquetamab) for the treatment of patients with relapsed or refractory multiple myeloma.
Talquetamab is an investigational, off-the-shelf, bispecific T-cell engager antibody targeting both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and separately targets CD3 on T cells.
This BLA is supported by data from the Phase I/II, first-in-human MonumenTAL-1 study of talquetamab (Phase I: NCT03399799; Phase II: NCT04634552) in patients with relapsed or refractory multiple myeloma who have received more than three prior lines of therapy. The first presentation of Phase II results from the MonumenTAL-1 study will be highlighted at the American Society of Hematology (ASH) Annual Meeting on December 10, 2022 in an oral scientific session (Abstract #157)2 and featured as part of the ASH Press Briefing.
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