Janssen Makes An EMA Marketing Application For Talquetamab For RRMM

(CTN News) – Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma.

Known as multiple myeloma, it is an incurable blood cancer that affects plasma cells, which are white blood cells found in the bone marrow.

Malignant plasma Janssen cells grow out of control in multiple myeloma. The European Union is expected to diagnose and treat over 50,900 cases of multiple myeloma by 2020, with more than 32,400 people dying from the disease.

Talquetamab is an investigational, off-the-shelf (or ready-to-use) bispecific T-cell engager antibody that targets both GPRC5D – a novel drug target that is expressed on some normal cells, but overexpressed on myeloma cells – and CD3 on T-cells.

A number of monotherapy and combination studies are currently being conducted using this drug. It is administered by subcutaneous injection.

Dr 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 severely pretreated multiple myeloma, since only 30% of triple-class-exposure patients respond to current treatment options.”

It is critical that innovative treatments, such as talquetamab, are available to patients as soon as possible. We look forward to working with the European Medicines Agency to achieve this.

It follows EMA’s approval of Janssen Talquetamab’s accelerated assessment in November 2022. Consequently, the timeframe for reviewing the MAA is reduced.

It is granted to medicinal products that are of major interest to public health and therapeutic innovation.

There are data supporting the MAA from the first-in-human MonumenTAL-1 study of talquetamab in patients with RRMM who have received more than three prior lines of therapy.

First phase 2 results were presented at ASH 2022, and phase 1 results were recently published in The New England Journal of Medicine.

A study presented at ASH 2022 showed that subcutaneous talquetamab achieved an overall response rate (ORR) of 74% at a dose of 0.4 mg/kg and 73% at a dose of 0.8 mg/kg when given every two weeks to myeloma patients who had previously received five or more lines of treatment.

Among these were proteasome inhibitors, immunomodulators, and anti-CD38 antibodies.

The submission in Europe marks another significant milestone in our efforts to transform the treatment of multiple myeloma,” said Dr. Peter Lebowitz, global therapeutic area head for oncology at Janssen Research & Development, LLC.

In December 2022, the EMA received a Biologics License Application (BLA) from the FDA.

Is Janssen owned by Johnson and Johnson?

Janssen Pharmaceutica was acquired by Johnson & Johnson, bringing to the company Janssen’s strong capabilities in the growing field of pharmaceutical medicines.

For Dr Paul Janssen, the global reach of Johnson & Johnson would enable him and his colleagues to help more patients.

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