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

Janssen (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 …

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