Janssen has 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-cells1.
In November 2022, the EMA granted accelerated assessment for talquetamab. Acceleratedassessment 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 innovation2.
This MAA is supported by data from the MonumenTAL-1 study of talquetamab. The first Phase 2 results from the study were presented at the 2022 American Society of Hematology (ASH) Annual Meeting and were selected for the Best of ASH session.
Edmond Chan, MBChB M.D. (Res), Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited 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.”
Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC 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.”
1 Pillarisetti K et al. A T-cell-redirecting bispecific G-protein-coupled receptor class 5 member D x CD3 antibody to treat multiple myeloma. Blood. 2020 Apr;135(15):1232-1243.
2 European Medicines Agency. Accelerated Assessment. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment. Last accessed: December 2022.