Janssen Seeks European Approval of Teclistamab

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational, off-the-shelf, T-cell redirecting, bispecific antibody, teclistamab, for the treatment of relapsed or refractory multiple myeloma (RRMM).

Teclistamab has already been granted accelerated assessment by the EMA in December 2021, which will reduce the timescale for MAA review by EMA’s Committee for Medicinal Products for Human Use (CHMP). Janssen’s MAA submission is supported by clinical trial data that have evaluated the safety and efficacy of the treatment.

“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,” said Edmond Chan MBChB MD (Res), senior director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited, in a Jan. 31, 2022 press release. “Today’s submission is an important step forward in our mission to improve outcomes for people living with multiple myeloma, where the need for new treatment strategies remains high.”

“We are pleased to announce the submission of teclistamab to the EMA. Once again, this shows our commitment to continue to provide innovative, transformative therapies for patients with relapsed or refractory multiple myeloma,” added Peter Lebowitz, MD, PhD, Global Therapeutic Area head, Oncology, Janssen Research & Development, LLC, in the press release.

Source: Janssen