The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for talquetamab to treat patients suffering with relapsed or refractory multiple myeloma (RRMM).
Talquetamab is an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody.
It targets both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and CD3 on T-cells.
Janssen-Cilag Limited senior director of EMEA therapeutic area lead haematology Edmond Chan said: “Despite advances, there remains a high unmet need for those with heavily pretreated multiple myeloma as only 30 percent of triple-class exposed patients respond to currently available treatment options.
“Innovative treatment approaches such as talquetamab, that engage novel cellular targets, are critical for improving outcomes for patients, and we look forward to working with the EMA to bring talquetamab to those in need of new options, as soon as possible.”
In November last year, the EMA awarded accelerated assessment for talquetamab.
Accelerated assessment cuts down the timeframe for an MAA to be reviewed and is awarded when a medicinal product is of major interest for public health and therapeutic innovation.
This MAA is backed by data from the Phase 1/2, first-in-human MonumenTAL-1 study of talquetamab in patients with RRMM who have received over three previous lines of therapy.
Janssen Research & Development Global Therapeutic Area head for oncology Peter Lebowitz said: “As we deepen our scientific understanding of multiple myeloma, we are focused on advancing our portfolio of innovative therapies to address this complex disease and the needs of patients.
“Today’s submission in Europe marks another important milestone in our progress and ambition to transform the treatment of multiple myeloma.”
The application to the EMA comes after a Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA) in December 2022 for approval of talquetamab to treat RRMM.