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Janssen submits marketing application for talquetamab

European Medicines Agency will consider therapy for the treatment of patients with multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA).

It concerns the approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). The therapy is an investigational, 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.

Meanwhile, the MAA is supported by data from the phase 1/2, first-in-human MonumenTAL-1 study of talquetamab relating to patients with RRMM who have received more than three prior lines of therapy.

The first phase 2 results from the study were presented at the 2022 American Society of Hematology Annual Meeting in an oral scientific session, while results from the phase 1 section of the study were recently published in The New England Journal of Medicine.

Edmond Chan, senior director EMEA therapeutic area lead haematology at Janssen-Cilag Limited, commented: “Despite advances, there remains a high unmet need for those with heavily pre-treated multiple myeloma as only 30% of triple-class exposed patients respond to currently available treatment options.”

He added: “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.”

“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,” concluded Peter Lebowitz, global therapeutic area head, oncology at Janssen Research and Development. “Today’s submission in Europe marks another important milestone in our progress and ambition to transform the treatment of multiple myeloma.”

In November 2022, the EMA granted accelerated assessment for talquetamab. This level of assessment reduces the timeframe for an MAA to be reviewed and is typically granted when a medicinal product is of significant interest for public health and therapeutic innovation.

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