Janssen Submits EMA Application for Multiple Myeloma Drug Candidate
Janssen has submitted a marketing authorization application to the European Medicines Agency for talquetamab to treat relapsed or resistant multiple myeloma.
Talquetamab is an investigational bispecific T-cell engager antibody targeting GPRC5D, a novel multiple myeloma target, and CD3, a protein complex that activates T cells to fight the cancer.
The application is supported by positive results from a phase 1/2 study of participants who had a median of five lines of therapy.
The company also submitted a biologics license application for the drug to the FDA in December 2022. The EMA granted the investigational drug an accelerated review in November 2022.