Janssen has submitted a marketing authorisation application (MAA) seeking approval of talquetamab in Europe for the treatment of patients with relapsed or refractory multiple myeloma (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 CD3 on T cells.
“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, Senior Director EMEA Therapeutic Area Lead Haematology, Janssen-Cilag.
“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, which reduces the timeframe for an MAA to be reviewed.
This MAA is supported by data from the Phase I/II, first-in-human MonumenTAL-1 study of talquetamab in patients with RRMM who have received more than three prior lines of therapy.
The application to the EMA follows a Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA) in December 2022 seeking approval of talquetamab for the treatment of RRMM.