Janssen submits BLA for talquetamab for RRMM to FDA

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application, or BLA, to the U.S. Food and Drug Administration for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma, or RRMM. 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. "Despite the therapies that have been developed for the treatment of multiple myeloma, there remains persistent unmet needs for patients who relapse or become refractory," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "Through our discovery and development of talquetamab, a novel GPRC5DxCD3 bispecific antibody, we remain relentlessly committed to the investigation of innovative therapies for patients and oncologists. We look forward to working closely with the FDA in their review of the talquetamab submission."