Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

BEERSE, BELGIUM, 3 January 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of 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.1

“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,” said Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “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 2022, the EMA granted accelerated assessment for talquetamab. Accelerated assessment reduces the timeframe for an MAA to be reviewed and is granted when a medicinal product is of major interest for public health and therapeutic innovation.2 

This MAA is supported by data from the Phase 1/2, first-in-human MonumenTAL-1 study of talquetamab (Phase 1: NCT03399799; Phase 2: NCT04634552) in patients with RRMM who have received more than three prior lines of therapy.3,4,5 The first Phase 2 results from the study were presented at the 2022 American Society of Hematology (ASH) Annual Meeting in an oral scientific session (Abstract #157).5 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.6

“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,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “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 follows a Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA) in December 2022 seeking approval of talquetamab for the treatment of RRMM