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Janssen submits marketing authorisation to EMA for teclistamab

The drug has been developed to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer


Janssen – a branch of Johnson & Johnson – has announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of teclistamab – a drug used to treat patients with relapsed or refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer affecting plasma cells – a type of white blood cell – found in bone marrow. If plasma cells become damaged, they can transform and grow in an abnormal way. The production of abnormal cells can result in an overcrowding in the bone marrow, suppressing the growth of healthy cells.

The majority of multiple myeloma patients are diagnosed with symptoms such as bone fracture or pain, low red blood cell counts, fatigue, high calcium levels or kidney failure. However, some patients living with the condition may initially experience no symptoms.

In 2020, more than 50,900 people were diagnosed with multiple myeloma and more than 32,500 patients died.

Edmond Chan, senior director, EMEA therapeutic area lead haematology, Janssen-Cilag said: “Despite the significant progress that has been made in the treatment of multiple myeloma, it remains an incurable cancer, with approximately half of newly diagnosed patients not reaching five-year survival and almost a third dying within one year of diagnosis.

“Today’s submission is an important step forward ... for people living with multiple myeloma, where the need for new treatment strategies remains high.”

Janssen’s application to the EMA follows a Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA), seeking the approval of teclistamab for the treatment of relapsed or refractory multiple myeloma.

In December 2021, the EMA issued an accelerated assessment for teclistamab. This form of assessment reduces the waiting time for the Committee for Medicinal Products for Human Use (CHMP) to review the MMA and is issued when a drug offers an innovative treatment option for patients.

Janssen’s submission to the EMA is supported by evidence from the MajesTEC-1 trial – an open-label, multicentre clinical trial assessing the safety and effectiveness of teclistamab in adults with relapsed or refractory multiple myeloma.

Updated findings from MajesTEC-1 trial data were recently presented at the American Society of Hematology 2021 annual conference.

Article by
Fleur Jeffries

1st February 2022

From: Regulatory



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