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Breakthrough Status

J&J’s Teclistamab Wins FDA Breakthrough Therapy Status

June 2, 2021

Johnson & Johnson’s (J&J) teclistamab has secured Breakthrough Therapy designation from the FDA as a treatment for relapsed or refractory multiple myeloma.

The bispecific antibody works by targeting both the B-cell maturation antigen and CD3 receptors to induce the killing of tumor cells.

J&J said the designation was supported by promising phase 1 data that will be presented June 8 at the 2021 American Society of Clinical Oncology Annual Meeting.

The drug received a Priority Medicine designation from the European Medicines Agency earlier this year.

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