www.fdanews.com/articles/202982-jjs-teclistamab-wins-fda-breakthrough-therapy-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.