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Janssen files for European authorization of bispecific antibody teclistama for multiple myeloma

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JanssenJanssen (NYSE:JNJ) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for approval of a T-cell redirecting, bispecific antibody to treat relapsed or refractory multiple myeloma (RRMM).

Known as teclistamab (JNJ-64007957), the bispecific antibody targets the B-cell maturation antigen (BCMA) and CD3.1.

In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA for approval of teclistamab to treat relapsed or refractory (R/R) multiple myeloma.

That same month, EMA granted accelerated assessment for teclistamab.

In the EMA application, Janssen included data from the MajesTEC-1 study testing teclistamab in adults with RRMM.

“We are pleased to announce the submission of teclistamab to the European Medicines Agency. Once again, this shows our commitment to continue to provide innovative, transformative therapies for patients with relapsed or refractory multiple myeloma,” said Dr. Peter Lebowitz, global therapeutic area head, oncology at Janssen Research & Development.

Filed Under: Oncology
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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